Methods for disinfecting medical connectors

ABSTRACT

Caps can be used to cover and sterilize the male luer of a medical connector. Some caps can create a seal with the male luer to prevent antiseptic from entering a lumen of the male luer. A biasing element can aid in creating or maintaining the seal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/171,997, titled STERILITY-PROTECTING CAPS WITH FLUIDRESERVOIR FOR SEPARATED CONNECTORS, filed Jul. 11, 2008, which is acontinuation-in-part of U.S. patent application Ser. No. 12/164,310,titled NESTABLE STERILITY-PROTECTING CAPS WITH FLUID RESERVOIR FORSEPARATED CONNECTORS, filed Jun. 30, 2008, which is acontinuation-in-part of U.S. patent application Ser. No. 12/014,388,titled NESTABLE STERILITY-PROTECTING CAPS FOR SEPARATED CONNECTORS,filed Jan. 15, 2008, which claims the benefit of U.S. ProvisionalApplication No. 60/880,541, titled ANTISEPTIC PROTECTIVE CAP FOR MALEAND FEMALE SCREW-TOGETHER CONNECTORS, filed Jan. 16, 2007, the entirecontents of each of which are hereby incorporated by reference herein.

BACKGROUND

1. Technical Field

The present disclosure generally relates to caps for medical connectorsand more specifically relates to caps that can be used to protect thesterility of unconnected medical connectors, such as connectors that maybe used for fluid flow or for fluid delivery systems.

2. Related Art

Bloodstream infections, such as may be caused by microorganisms thatenter patients via intravascular catheters, are a significant cause ofillness and excess medical costs. A substantial number of suchinfections occur in U.S. intensive care units annually. Additionally, asignificant fraction of these infections result in death.

Guidelines from the Centers for Disease Control and Prevention describevarious ways to limit bloodstream infections in hospital, outpatient,and home care settings. The guidelines address issues such as handhygiene, catheter site care and admixture preparation. However, despitethese guidelines, such infections continue to plague healthcare systemsat relatively unchanged rates.

Impregnating catheters with various antimicrobial agents is one approachfor reducing these infections. Impregnated catheters, however, provideless than satisfactory results. Additionally, some microbes havedeveloped resistance to the various antimicrobial agents used in thecatheters. Other systems and approaches have also been developed, butthese likewise suffer from a variety of limitations and drawbacks.

SUMMARY

Disclosed herein are sterility caps, and related systems and methods,that can reduce the threat of microorganisms entering the bloodstream ofa patient via fluid flow or fluid delivery systems, such as, forexample, needleless injection sites and/or fluid transfer devices havinga male luer. In some embodiments, a cap is configured to couple with andsterilize a medical connector having a male luer. In furtherembodiments, the cap can include an antiseptic, and can be configured tocreate a seal with the male luer so as prevent antiseptic from enteringa lumen of the male luer. Other or further features of variousembodiments are also disclosed and are set forth in the appended claims,which are hereby incorporated by reference in this summary section.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation view of an embodiment of an assembly thatincludes an attached pair of medical caps;

FIG. 1A is an end perspective view of the caps of FIG. 1;

FIG. 1B is an end perspective view of the caps of FIG. 1 shown from avantage point opposite of that shown in FIG. 1A;

FIG. 2 is an exploded perspective view of the medical caps of FIG. 1;

FIG. 3 is a perspective view of a first of the medical caps of FIG. 1,which shows internal threads;

FIG. 4 is a perspective view of the cap of FIG. 3 and an associatedmedical connector about to be connected therewith;

FIG. 5 is a perspective view of a second of the caps of FIG. 1 and aluer lock connector to which the male cap may be affixed;

FIG. 6 is a side elevation view of an attached pair of medical caps,similar to the caps of FIG. 1, but having an embodiment of a sealingmechanism disposed about connecting edges of the caps;

FIG. 7 is an exploded side elevation view of the cap assembly of FIG. 6;

FIG. 7A is a perspective view of one of the caps of FIG. 7 with asealing mechanism disposed thereon;

FIG. 7B is a perspective view of the other cap of FIG. 7 with a sealingmechanism disposed thereon;

FIG. 8A is a side elevation view of the interconnected cap assembly ofFIG. 6 with an embodiment of a seal partially displaced about connectingedges of the cap assembly;

FIG. 8B is a side elevation view of the interconnected cap assembly ofFIG. 8A with the seal fully in place;

FIG. 9A is a side elevation view of the cap portion of FIG. 3 and anabsorbent pad positioned above the cap portion;

FIG. 9B is a side elevation view of the cap portion and pad of FIG. 9Aschematically showing the absorbent pad disposed within the cap portion;

FIG. 9C is a side elevation view of the cap portion and pad of FIG. 9Bwith a quantity of antiseptic material being dispensed into the cap andpad;

FIG. 9D is a perspective view of the cap portion containing the pad ofFIGS. 9B and 9C affixed to an associated complementary cap;

FIG. 9E is a side elevation view of the cap portion of FIG. 5 and anabsorbent pad disposed therein;

FIG. 10 is a cross-sectional perspective view of another embodiment ofan assembly that includes a pair of caps, which are attached to eachother via a threaded interface;

FIG. 11 is an exploded perspective view of the assembly of FIG. 10showing the caps detached from each other;

FIG. 12 is a cross-sectional perspective view of another embodiment ofan assembly that includes a pair of caps, which are attached to eachother via a snapping interface;

FIG. 13 is a cross-sectional perspective view of another embodiment ofan assembly that includes a pair of caps, which are attached to eachother via a friction-fit interface;

FIG. 14 is a cross-sectional perspective view of another embodiment ofan assembly that includes a pair of caps, which are attached to eachother via a press-fit interface;

FIG. 15 is a cross-sectional perspective view of the assembly of FIG. 14showing the caps detached from each other;

FIG. 16 is a cross-sectional perspective view of another embodiment ofan assembly that includes a pair of caps, which are attached to eachother via a welded interface;

FIG. 17 is a cross-sectional perspective view of the assembly of FIG. 16showing the caps detached from each other;

FIG. 18 is a perspective view of another embodiment of an assembly thatincludes a pair of caps, which are attached to each other at leastpartially via a snapping interface;

FIG. 19 is a perspective view of the assembly of FIG. 18 showing thecaps detached from each other;

FIG. 20 is a perspective view from a different angle of one of the capsof FIG. 18;

FIG. 21 is a perspective view from a different angle of another of thecaps of FIG. 18;

FIG. 22 is a perspective view of another embodiment of an assembly thatincludes a pair of caps, which are attached to each other via a snappinginterface;

FIG. 23 is a side elevation view of an embodiment of a cap that iscompatible with at least the assemblies of FIGS. 18 and 22;

FIG. 24 is a cross-sectional view of another embodiment of an assemblythat includes a pair of caps, which are attached to each other via asleeve;

FIG. 25 is a perspective view of another embodiment of an assembly thatincludes two cap portions integrally connected to each other;

FIG. 26 is an exploded perspective view of the assembly of FIG. 25;

FIG. 27 is a perspective view focusing on one cap portion of theassembly of FIG. 25, with covers removed from the assembly;

FIG. 28 is a perspective view focusing on the other cap portion of theassembly of FIG. 25, with covers removed from the assembly;

FIG. 29 is a cross-sectional view of the assembly of FIG. 28 taken alongthe view line 29-29;

FIG. 30 is a cross-sectional view of the assembly of FIG. 25 showing anearly stage of coupling a cap portion of the assembly with a medicalconnector that has a male luer;

FIG. 31 is a cross-sectional view of the assembly of FIG. 25 showing alate stage of coupling the cap portion of the assembly with the medicalconnector that has a male luer;

FIG. 32 is a cross-sectional view of the assembly of FIG. 25 showing alate stage of coupling the other cap portion of the assembly with afirst embodiment of a needleless injection site;

FIG. 33 is a cross-sectional view of the assembly of FIG. 25 showing alate stage of coupling the other cap portion of the assembly with asecond embodiment of a needleless injection site;

FIG. 34 is a cross-sectional view of the assembly of FIG. 25 showing alate stage of coupling the other cap portion of the assembly with athird embodiment of a needleless injection site;

FIG. 35 is a cross-sectional view of another embodiment of an assemblythat includes two cap portions integrally connected to each other, withcovers removed from the assembly;

FIG. 36 is an exploded perspective view of another embodiment of anassembly that includes two cap portions integrally connected to eachother;

FIG. 37 is a cross-sectional view of the assembly of FIG. 36 similar tothe view shown in FIG. 29;

FIG. 38 is a cross-sectional view of the assembly of FIG. 36 showing anearly stage of coupling a cap portion of the assembly with a medicalconnector that has a male luer;

FIG. 39 is a cross-sectional view of the assembly of FIG. 36 showing alate stage of coupling a cap portion of the assembly with a medicalconnector that has a male luer;

FIG. 40 is an exploded perspective view of another embodiment of a capconfigured for coupling with a medical connector having a male luer;

FIG. 41 is a cross-sectional view of the assembled cap of FIG. 40showing an early stage of coupling the cap with a medical connector thathas a male luer in which the male luer has not yet contacted a sealingmember of the cap;

FIG. 42 is a cross-sectional view such as that of FIG. 41 showing alater stage of coupling the cap with the medical connector in which themale luer forms a fluid-tight seal with the sealing member of the cap;

FIG. 43 is a cross-sectional view such as that of FIG. 41 showing a yetlater stage of coupling the cap with the medical connector in which apad is compressed so as to expel antiseptic therefrom through thesealing member and in which the male luer has not yet formed afluid-tight seal with a sidewall of the medical connector;

FIG. 44 is a cross-sectional view such as that of FIG. 41 showing a yetlater stage of coupling the cap with the medical connector in which thepad is compressed further so as to expel additional antiseptic therefromthrough the sealing member and in which the male luer has not yet formeda fluid-tight seal with a sidewall of the medical connector;

FIG. 45 is a cross-sectional view such as that of FIG. 41 showing a yetlater stage of coupling the cap with the medical connector in which thatpad is compressed even further so as to expel additional antiseptictherefrom through the sealing member and in which the male luer forms afluid-tight seal with a sidewall of the medical connector;

FIG. 46 is a cross-sectional view such as that of FIG. 41 showinganother embodiment of cap coupled with a medical connector having a maleluer;

FIG. 47 is a cross-sectional view of another embodiment of a capconfigured for coupling with a medical connector having a male luer;

FIG. 48 is a cross-sectional view of yet another embodiment of a capconfigured for coupling with a medical connector having a male luer;

FIG. 49 is a cross-sectional view of the cap of FIG. 48 coupled with amedical connector having a male luer;

FIG. 50 is an exploded perspective view of another embodiment of anassembly that includes a female cap and a male cap, which can beconnected in a pre-use configuration via a sleeve;

FIG. 51 is a cross-sectional view of the female cap of FIG. 50 takenalong the view line 51-51;

FIG. 52 is a cross-sectional view of the male cap of FIG. 49 taken alongthe view line 52-52;

FIG. 53 is a cross-sectional view of the sleeve of FIG. 49 taken alongthe view line 53-53;

FIG. 54 is an elevation view of the assembly of FIG. 50 shown in apre-use configuration;

FIG. 55 is an exploded perspective view of another embodiment of anassembly that includes a female cap and a male cap, which can beconnected in a pre-use configuration via a sleeve and that includesseparation assists;

FIG. 56 is an elevation view of an embodiment of a cap that includes aseal inhibitor;

FIG. 57 is another elevation view of the cap of FIG. 56 showing adifferent face thereof; and

FIG. 58 is an elevation view of the cap of FIG. 56 coupled with aremovable cover.

DETAILED DESCRIPTION

Disclosed herein are caps that can be used to protect and/or sterilizemedical connectors. Systems and methods related to such caps are alsodisclosed. An example of medical connectors for which caps disclosedherein may be used are intravascular connectors associated with a fluidpathway, such as an IV line. Commonly, a fluid pathway is used tointermittently administer medications to a patient. For example, a fluidpathway, which communicates fluids with a patient's blood stream, mayhave one or more connectors associated therewith. Each of the fluidpathway connectors can be connected to other connectors, such as aconnector associated with a central line. In such a situation, themedical connectors, such as luer lock connectors, are connected anddisconnected at various times, and may remain disconnected for severalminutes or hours. Medical connector caps are used to cover and protectthe various medical connectors while the connectors are separated fromone another. When the medical connectors are separated from each other,there are two connectors that each can benefit from being covered by acap. Therefore, in some cases, it can be advantageous to have a singleconnector set that can be used to provide protection for both ends of aseparated connection. In other or further embodiments, a cap can includean antiseptic for sterilizing a medical connector. In some cases, it canbe advantageous for the cap to form a seal with the medical connector tothereby prevent the antiseptic from exiting the cap into the fluidpathway.

Shown in FIGS. 1-1B, is a system, unit, or assembly 100 of a pair ofseparable caps 102 and 104, which are securely, but releasably, affixedone to the other across a common interface 106. Internal parts andsurfaces of the assembly 100 are sterile and are able to reduce,prevent, or eliminate contamination of connectors with which caps 102,104 can be coupled.

As further discussed below, in various embodiments, caps 102 and 104 canbe distributed in a coupled state, such as that shown in FIGS. 1-1B, andmay be decoupled by a user (e.g., a medical professional) andsubsequently coupled with connectors. Caps 102 and 104 can includefeatures to aid in such a decoupling action and/or in the coupling ofcaps 102, 104 with the respective connectors. For example, in theillustrated embodiment, each cap 102, 104 includes gripping features103.

The gripping features 103 can comprise longitudinally extending lands orridges 105 that taper from a relatively wide width near the interface106 of the caps 102, 104 to a narrower width at or near an outer end ofthe cap 102, 104. The gripping features 103 can further includelongitudinally extending depressions or grooves 107 between adjacentridges 105. For example, as can be seen in FIGS. 1-8B, the grooves 107can extend radially inwardly from an outer surface of the cap 102 thatcomprises the ridges 105, and the grooves 107 can also commence at aposition near the interface 106 and can grow wider and deeper toward anouter end of the cap 102. The gripping features 103 can further includelongitudinally extending bumps or protrusions 108 between adjacentridges 105. As can be seen in FIGS. 1-8B, the protrusions 108 can extendradially outwardly from an outer surface of the cap 104 that comprisesthe ridges 105, and the protrusions 108 can also commence at a positionnear the interface 106 and can grow wider and taller toward an outer endof the cap 104. The uneven surfaces provided by the ridges 105 and thegrooves 107 or protrusions 108 can facilitate rotational movement of thecaps 102, 104 (e.g., rotational movement relative to each other), whichcan aid in decoupling the caps 102, 104 from each other and/or securingthe caps 102, 104 to separated connectors. For example, the unevensurfaces may be easily gripped by the fingertips of a medicalpractitioner.

As can be seen, for example, in FIGS. 1A and 1B, the patterns of theridges 105, grooves 107, and/or protrusions 108 can be different for thecaps 102, 104. In the illustrated embodiment, cap 102 includes onlyridges 105 and grooves 107, whereas cap 104 includes only ridges 105 andprotrusions 108. Such differences can aid in distinguishing the caps102, 104 from each other. Other features and methods for distinguishingthe caps 102, 104 from each other are discussed further below.

Caps 102 and 104 are shown as separated from each other, or in adecoupled state, in FIG. 2, wherein cap 104 is shown as having aninsertable or male section 108. Section 108 has an elongated portion 110that ends at an exteriorly disposed threaded segment 112. Threadedsegment 112 comprises threads 114 that are sized and shaped to beinserted and joined by threading into cap 102.

Cap 102, as shown in FIG. 3, has a closed, hollow interior 116, whichmay also be referred to as a sterilization cavity or chamber, whichopens outwardly at a proximal end 118 to expose an interiorly disposedthreaded segment 120 that includes threads 122. Threads 122 are of asize and pitch to complementarily engage threads 114 of cap 104 for ascrew or push-on tight fit with cap 104.

As illustrated in FIG. 4, cap 102 has an interior surface 124, anopening edge 126 and an exterior surface 128, opening edge 126 being acommon link between interior surface 124 and exterior surface 128.Further, threads 122 also have a size and pitch to engage a threadablesegment 130 of a female connector, such as for example, female luerconnector 132. Such connectors are generally and commonly used ascatheter and other fluid-tight protective connectors in medicalapplications. As seen in FIG. 4, cap 102 provides a protective cover forconnector 132 when encased about connector 132 (displaced in directionof arrow 134) whereupon threadable segment 130 engages and is drawn intoa secure, but releasable connection with threads 122 of cap 102.

In some embodiments, the connector 132 comprises a needleless injectionsite, which may sometimes referred to as a needleless injection port,hub, valve, or device, or as a needleless access site, port, hub, valve,or device, and which can include such brands as, for example, Clave®(available from ICU Medical, Inc.), SmartSite® (available from CardinalHealth, Inc.), and Q-Syte™ (available from Becton, Dickinson andCompany). Stated otherwise, in some embodiments, cap 102 can be suitablyconnected with any of a variety of different needless injection sites,such as those previously listed. In certain embodiments, once cap 102has been applied to or coupled with connector 132, it is unnecessary todisinfect (e.g. treat with an alcohol swab) the connector 132 prior toeach reconnection of the connector 132 with another connector, as theconnector 132 will be kept in an uncontaminated state while coupled withthe cap 102. Use of the cap 102 thus can replace the standard swabbingprotocol.

As seen in FIG. 5, threads 114 of cap 104 are of a size and pitch toengage threads 138 of a male luer-lock connector 136. For example,connector 136 can comprise the end of an IV tubing set that isdisconnected from an IV catheter needleless injection site. Note thatcap 104 has a medially disposed, elongated hole 140, which may also bereferred to as a sterilization chamber, into which a frustoconical luer142 of connector 136 may be facilely and securely inserted when cap 104is displaced in the direction of arrow 144 to engage connector 136.

Cap 104 also has a surface 146 which continues through to a circularedge 148. Further, distally displaced from circular edge 148, surface146 abruptly ends at a circular ring shaped edge 150, which is therefromjoined to an outside surface 152. It may be noted that opening edge 126(see FIG. 4) and ring shaped edge 150 combine to form common interface106 (see FIG. 1) when cap 102 is affixed to cap 104 to constructassembly 100. It should also be noted that, in certain embodiments,surfaces of assembly 100, which contact internal surfaces of aconnector, such as connector 132 or connector 136, are sufficientlysterile to not contaminate the inner surfaces thereof.

Internal portions and associated edges of caps 102 and 104 can bepre-sterilized and so maintained until use. Caps 102 and 104 may beinjection molded using polypropylene or other material that can besterilized and which is impervious to contaminating agents while cap 102is nested with cap 104, before being opened for use. Caps 102 and 104can also be impregnated or coated with an antimicrobial substance. As anexample, each cap 102 and cap 104 may be individually sterilized byethylene oxide (ETO) before final assembly and aseptically paired, orassembly 100 may be finally consolidated as a single unit and thensterilized, such as by radiation (e.g. gamma). Even so, assembly 100should be kept intact until time for use, with internal surfaces ofnested parts 102 and 104 remaining clean and sterile until assembly 100is opened for use.

Reference is now made to FIGS. 6 through 7B, wherein a seal, such as an“O” ring, is disposed between surfaces 126 and 150 to provide yetanother barrier against internal surface contamination of caps 102 and104. As seen in FIG. 6, an “O” ring 154 is disposed between surfaces 126and 150 to provide a seal thereby. While “O” ring 154 can be displacedfrom caps 102 and 104 as illustrated in FIG. 7, it is anticipated that“O” ring 154 can be adapted to remain affixed to one of caps 102 and104. For example, as illustrated in FIG. 7A, “O” ring 154 can remainpositioned adjacent surface 150 on cap 104 when caps 102 and 104 aredisconnected from one another, rather than being separated when cap 104is displaced from cap 102, as seen in FIG. 7.

Alternatively, “O” ring 154 can be associated with cap 102, as seen inFIG. 7B. In particular, opening edge 126 of cap 102 can have an annulargroove 156 for receiving “O” ring 154 therein. Annular groove 156 can besized and shaped such that “O” ring 154 sealingly engages cap 104 or amedical connector when cap 102 is coupled thereto. It will beappreciated that annular groove 156 can be disposed in opening edge 126toward the exterior of cap 102 as illustrated in FIG. 7B, or annulargroove 126 can be disposed in opening edge 126 towards the interior ofcap 102. In some exemplary embodiments, opening edge 126 of cap 102 doesnot have annular groove 126 therein. In such embodiments, “O” ring 154can be mounted directly to opening edge 126. “O” ring 154 can be mountedon or to caps 102 or 104 in any suitable manner, including with the useof an adhesive, such as glue, a mechanical fastener, or a frictionfitting.

While the seal between caps 102 and 104 has been described as being an“O” ring mounted on one of caps 102 or 104, it will be appreciated thatother seals are contemplated. For example, each of caps 102 and 104 canhave an “O” ring mounted thereon. In such a configuration, the two “O”rings abut each other when caps 102 and 104 are coupled together,thereby forming a seal to antiseptically partition the internal andexternal surfaces of caps 102 and 104. In an alternate embodiment, an“O” ring or other sealing mechanism can be mounted on surfaces 109 a and109 b. Alternatively, one or both of caps 102 and 104 can be formed witha lip, bump, or groove that provides a sealing function when caps 102and 104 are coupled to each other or to separated medical connectors. Inone exemplary embodiment, one of caps 102 and 104 has a ridge extendingaround its interfacing surface, and the other cap has a correspondinggroove in its interfacing surface into which the ridge is received tocreate the seal. In yet another exemplary embodiment, one or both ofcaps 102 and 104 can be overmolded or comolded using any known andsuitable overmolding or comolding process. For example, one or both ofcaps 102 and 104, and associated surfaces 126 and 150, can be overmoldedor comolded. Thus, caps 102 and 104 can be formed of a polymer, andsurfaces 126 and 150 can be formed of a softer polymer that is comoldedor overmolded to the rest of caps 102 or 104. Surfaces 126 and 150,formed of the softer polymer, are thus able to be compressed or deformedsufficiently to create an impermeable seal when caps 102 and 104 arecoupled together or coupled to separated medical connectors.

As noted elsewhere herein, a sealing mechanism, as described herein, canbe used to limit or prevent evaporation or loss of an antiseptic agentdisposed within caps 102 and 104 when caps 102 and 104 are coupledtogether. Additionally, a sealing mechanism, as described herein, canalso limit or prevent evaporation or loss of an antiseptic agentdisposed within caps 102 and 104 when caps 102 and 104 are coupled toseparated medical connectors. Further, a sealing mechanism, as describedherein, can also limit or prevent microbial ingress within caps 102 and104 when they are coupled to each other, or within caps 102 and 104 whencaps 102 and 104 are individually coupled to separated medicalconnectors. Moreover, a sealing mechanism, as described herein, can beadapted to maintain an antiseptic agent within caps 102 and 104 whencaps 102 and 104 are either coupled to one another or to separatedmedical connectors for a predetermined amount of time. Thus, the sealmay be adapted to limit or prevent microbial ingress, while alsopartially or completely preventing evaporation of an antiseptic agentdisposed within caps 102 and 104 when caps 102 and 104 are coupledtogether or when caps 102 and 104 are coupled to separated medicalconnectors. Similarly, the seal may be adapted to limit or preventmicrobial ingress while not preventing evaporation of an antisepticagent disposed within caps 102 and 104. In yet other embodiments, noseal is provided between caps 102 and 104 when coupled together orbetween caps 102 and 104 when coupled to separated medical connectors.

Further safety in sealing against internal surface contamination may beprovided by a sealing tape, or a planar or foil seal, such as tape 158seen in FIG. 8A. Tape 158 is disposed to fully cover exposed edges ofsurfaces 126 and 150. Tape 158 may, for example, be of an imperviouspliable material, such as a metallized-surface mylar. As seen in FIG.8B, tape 158 is wrapped about surfaces 126 and 150 to provide a secureseal. It is preferred that tape 158 frangibly divides when cap 102 isseparated from cap 104 to facilitate separation of caps 102 and 104 andprovide a visible indication that the seal is broken. Thus tape 158provides both a seal to prevent microbial ingress and a mechanism formaintaining the secure connection between caps 102 and 104 prior to use.It will be appreciated, however, that any suitable sealing mechanism canbe used to maintain the secure connection between caps 102 and 104 priorto use. For example, any sealing mechanism can be used that securely andselectively couples caps 102 and 104 together, requires deliberateaction to break the seal, and provides a visual indication of whetherthe seal has been broken. By way of example and not limitation, asuitable sealing mechanism may include a heat stake, a frictional seal,a barbed seal, a ratchet seal, and the like.

When capping disconnected medical connectors, it can be desirable to domore than merely cover the connectors. For example, an absorbent pad,such as pad 160, seen in FIG. 9A, may be included within cap 102 (e.g.,within the sterilization chamber 116), such as by displacing pad 160into cap 102 as indicated by arrow 162. Pad 160 is seen disposed in cap102 in FIG. 9B. An antiseptic 164 can also be disposed within cap 102 asillustrated in FIG. 9C. Antiseptic 164 can be in liquid or solid form.For example, alcohol or another stable liquid antiseptic may be addedfrom a container 166 to be received within, wet, soak, or saturate pad160 to a predetermined concentration level. Note that once assembly 100is fully assembled, pad 160 will substantially remain at thepredetermined concentration level due to the exterior seals provided forassembly 100 as described herein. Alternatively, or additionally, pad160 may receive or be impregnated with a dry antiseptic, such as, forexample, chlorhexidine gluconate.

Further note that once cap 104 is securely affixed to cap 102, as seenin FIG. 9D, pad 160 is disposed to contact at least circular edge 148(see also FIG. 5). (In FIG. 9D, parts of cap 104 which are internal toassembly 100 are seen with hidden or dashed lines.) Such contactprovides a wiping action preferred to make contact with a surface beforecontact is made with an associated connector. Note also that residualantiseptic on associated internal surfaces of cap 104 may be transferredto related parts of the associated connector for cleaning and/ordisinfecting purposes.

Pad 160 can be formed of a deformable, resilient material such that whencap 104 is coupled to cap 102, elongated portion 110 can compress pad160 within cap 102, as illustrated in FIG. 9D. Further, pad 160 canexpand to its original shape when cap 104 is removed from cap 102.Similarly, pad 160 can be compressed within cap 102 when cap 102 iscoupled to a medical connector, such as medical connector 132. Morespecifically, during the connection of cap 102 to a medical connector,cap 102 and pad 160 rotate relative to an opening edge of the medicalconnector, thereby drawing the medical connector into cap 102. Therotation of cap 102 causes pad 160 to wipe or scrub the opening edge ofthe medical connector. Pad 160 and any antiseptic disposed within cap102 can thus cleanse and disinfect the opening edges of the medicalconnector. Pad 160 can also be formed such that when a medical connectoris coupled to cap 102, pad 160 is deformed such that pad 160 extendsaround the opening edges and/or threads of the medical connector. Forexample, pad 160 can be formed such that as cap 102 is twisted ontomedical connector 132, pad 160 deforms around threads 130 and/or theopening edges of medical connector 132, thereby scrubbing threads 130and/or the opening edge of medical connector 132.

Pad 160 can also provide additional functionality when a liquidantiseptic is disposed within cap 102. In particular, pad 160 acts as asponge to absorb or release the liquid antiseptic within cap 104. Morespecifically, when pad 160 is compressed by elongate portion 110 of cap104 (FIG. 9D; see also elongate portion 268 compressing pad 160 in FIG.14) or the opening edges of a medical connector coupled to cap 102, pad160 releases at least a portion of the antiseptic so that the antisepticcan be transferred to elongate portion 110 or the opening edges of themedical connector. Conversely, when cap 102 or a medical connector isdisconnected from cap 102, pad 160 expands and absorbs excess antisepticso that the antiseptic does not drip or spill out of cap 102.

Similar to pad 160 and antiseptic 164 disposed within cap 102, cap 104may also have a pad and/or an antiseptic disposed therein. For example,as illustrated in FIG. 9E, a pad 170 may be disposed within elongatehole 140 of cap 104. An antiseptic can also be disposed within cap 104in a manner similar to antiseptic 164 in cap 102. Antiseptic can be inliquid or solid form. For example, alcohol or another stable liquidantiseptic may be added from a container to saturate pad 170 to apredetermined level. Alternatively, or additionally, pad 170 may beimpregnated with a dry antiseptic, such as chlorhexidine gluconate. Onceassembly 100 is fully assembled, an antiseptically saturated pad 170disposed within cap 104 will substantially remain at the predeterminedsaturation level due to the exterior seals for assembly 100 as describedabove. Once caps 102 and 104 are disconnected from each other andconnected to individual medical connectors, pad 170 disposed within cap104 may scrub related parts of the associated connector for cleaningand/or disinfecting purposes. It will be appreciated, however, that insome embodiments, pad 170 may not contact a medical connector coupled tocap 104. Additionally, the antiseptic disposed within cap 104 may betransferred to the related parts of the associated medical connector forcleaning and/or disinfecting purposes.

Additional embodiments of caps such as the caps 102, 104 are provided inFIGS. 10-29 and the associated written description of U.S. patentapplication Ser. No. 12/171,997, titled STERILITY-PROTECTING CAPS WITHFLUID RESERVOIR FOR SEPARATED CONNECTORS, which was filed on Jul. 11,2008 and was published as U.S. Patent Application Publication No.2009/0062766 on Mar. 5, 2009 (“the Publication”), which is herebyincorporated by reference herein. As indicated in the Publication, anysuitable feature of the illustrative embodiments of FIGS. 16-29 of thePublication, which are described with respect to a female-type capsimilar to the cap 102, may be applied to or incorporated within amale-type cap, similar to the cap 104. Likewise, the female-type capsdescribed with reference to FIGS. 16-29 of the Publication can becoupled to a male-type cap in a manner similar to that described withreference to caps 102 and 104, in which the caps 102, 104 are nestedwith each other. In other embodiments, any suitable feature of the capsdescribed with respect to FIGS. 1-29 of the Publication, whether of amale or female variety, can be formed and/or employed without beingnested or otherwise associated with a complementary cap.

Discussed hereafter are additional embodiments of caps, which can havecoupling arrangements and/or other features that differ in certainrespects from those of the caps 102, 104 described above and other capsdescribed in the Publication. Any suitable feature of such caps can beincorporated into the caps described hereafter, and vice versa.

FIGS. 10 and 11 depict a system or assembly 1000 that includes a firstprotective medical connector, shield, or cap 1002 and a secondprotective medical connector, shield, or cap 1004. As shown in FIG. 10,the caps 1002, 1004 are connected to each other when the assembly 1000is in a shipping or pre-use state. As shown in FIG. 11, the caps 1002,1004 can be separated from each other such that each may be coupled witha corresponding or complementary medical connector. For example, as withthe cap 102, the cap 1002 can be configured to couple with a femaleconnector, such as a female luer lock or a needleless injection site(see, e.g., FIG. 4). Accordingly, the cap 1002 may be referred to as afemale cap. As with the cap 104, the cap 1004 can be configured tocouple with a male connector, such as a male luer lock (see, e.g., FIG.5). Accordingly, the cap 1004 and may be referred to as a male cap.

With continued reference to FIGS. 10 and 11, the cap 1002 can comprise ahousing 1010. The housing 1010 can be elongated, and may define acylinder or any other suitable shape. For example, in the illustratedembodiment, the housing 1010 includes a sidewall 1012 that defines asubstantially cylindrical outer surface 1014. The outer surface can besmooth, as shown, which can enhance comfort to a patient if the cap 1002contacts the patient when coupled with a medical connector. In otherembodiments, the outer surface can include gripping features, which canaid in rotating the cap 1002 relative to the cap 1004 to permitseparation of the caps 1002, 1004 and/or aid in rotating the cap 1002relative to a medical connector. Such gripping features can include, forexample, ridges, grooves, an/or protrusions similar to the ridges 105,grooves 107, and protrusions 108 described above and/or an elastomericor other coating or layer having a relatively high coefficient offriction. The sidewall 1012 can define a sealing surface 1016 at one endthereof and can define a terminal edge 1018 at an opposite end thereof.

The housing 1010 can further include a transverse wall or partition1020. In the illustrated embodiment, the partition 1020 defines a planethat is substantially perpendicular to a longitudinal axis of thesidewall 1012. A first portion of the sidewall 1012 can cooperate withone side of the partition 1020 to define a sterilization chamber 1022,which is closed at one end by the partition 1020 and open at an oppositeend thereof (e.g., the sealing surface 1016 can define an open end ofthe sterilization chamber 1022). Similarly, a second portion of thesidewall 1012 can cooperate with an opposite side of the partition 1020to define a coupling chamber 1024, which likewise is closed at one endby the partition 1020 and open at an opposite end thereof (e.g., theterminal edge 1018 can define an open end of the coupling chamber 1024).

An interior surface the sidewall 1012 can include a connection interface1030 in the region of the sterilization chamber 1022. The connectioninterface 1030 can comprise inwardly projecting threads 1031 similar tothe threads 122 described above, and can be configured tocomplementarily engage a connection interface of a medical connector,such as, for example, outwardly projecting threads of a needlelessinjection site. The threaded connection interface 1030 thus can allowfor selective coupling of the cap 1002 to a medical connector in asecure, yet selectively removable fashion. Other configurations of theconnection interface 1030 may permit the cap 1002 to be coupled with amedical connector in a secure, yet selectively removable fashion, suchas friction-fit, snap-fit, or other suitable interfacing arrangements.

The sterilization chamber 1022 can include a pad 1032 therein. The pad1032 can resemble the pads 160, 170 described above. In variousembodiments, the pad 1032 can be deformable, and can also be configuredto retain an antiseptic 1033, such as, for example, the antiseptic 164described above. In further embodiments, the pad 1032 can be resilientlydeformable. For example, the pad 1032 can comprise any suitablesponge-like material, such as an elastomeric foam, any open-cell foam,felt, or non-woven fiber matrix, and can be configured to conform to thecontours of a portion of a medical connector that is introduced into thesterilization chamber 1022 (e.g., uneven surfaces of an end of aneedleless injection site; see also FIGS. 32-34 and the associatedwritten description herein). The pad 1032 can also comprise anyclosed-cell foam, as well as a solid elastomeric foam such as Silicon orthe like.

The pad 1032 can have a series or network of openings or spaces thereinthat can retain the antiseptic 1033 when the pad 1032 is in an expandedstate. For example, the antiseptic 1033 can be received within, occupy,fill (or partially fill), wet, soak, or saturate at least a fraction ofthe pad 1032, or stated otherwise, can fill the pad 1032 to a givenconcentration level. Compression of the pad 1032 can cause antiseptic1033 to egress from the pad 1032 so as to contact the medical connector.Resilient expansion of the foam upon removal of a compressive force canallow the pad 1032 to soak up or absorb at least some of the antiseptic1033 that had previously been forced from the pad 1032. In someembodiments, the antiseptic 1033 can comprise any liquid antiseptic,such as alcohol, Isopropyl alcohol at various concentrations rangingfrom 50-90%, ethanol at various concentrations ranging from 50-95%, andcombinations of any alcohols with any antiseptics, or a dry material,such as chlorhexidine, ethylenediaminetetraacetic acid (EDTA),lodaphors, or any combination thereof. Accordingly, although theantiseptic 1033 is schematically depicted in FIG. 10 as a series ofdroplets, the antiseptic 1033 is not necessarily liquid and may fill thepad 1032 to a greater or lesser extent. In the illustrated embodiment,when the sterilization chamber 1022 is in a sealed state (e.g., in itspre-use condition), the pad 1032 is in a relaxed, expanded, oruncompressed state in a longitudinal direction. It is noted that the pad1032 may be uncompressed in one or more dimensions, yet compressed inone or more other dimensions, when the assembly 1000 is in the pre-usestate. For example, the pad 1032 can be expanded or in a relaxed statein a longitudinal direction, yet compressed radially inwardly via thesidewall 1012, when the assembly 1000 is in the pre-use state. Such alack of compression of the pad 1032 in the longitudinal direction canresult from the fact that the cap 1004 does not interact with theconnection interface 1030 of the cap 1002 to seal the cap 1002, and thusno portion of the cap 1004 contacts the pad 1032 when the caps 1002,1004 are in the pre-use configuration.

In the illustrated embodiment, the pad 1032 is substantially cylindricaland defines an outer diameter that is approximately the same size as aninner diameter of the threads 1031. In other embodiments, the outerdiameter of the pad 1032 can be larger than the inner diameter of thethreads 1031 so as to be radially compressed and held tighter within thesterilization chamber 1022. In further embodiments, the pad 1032 caninclude threading that projects radially inwardly and that iscomplementary to the threads 1031 to thereby secure the pad 1032 withinthe chamber 1022.

The sterilization chamber 1022 can be sealed at the sealing surface 1016via a cover 1034 that can span an open end of the sterilization chamber1022. The cover 1034 can be secured to the housing 1010 in any suitablemanner, such as, for example, via an adhesive. Preferably, the cover1034 can be readily removed by a practitioner. For example, in someembodiments, the cover 1034 can include a tab 1035 and a practitionercan readily remove the cover 1034 by holding the housing 1010 in onehand and pulling the tab 1035 away from the housing 1010 with the otherhand. The removable cover 1034 can be formed of any suitable material,such as, for example, an impervious pliable material (e.g., foil,plastic, metallized-surface mylar, and the like). The cover 1034 canprovide a hermetic seal that can assist in maintaining the sterility ofthe sterilization chamber 1022 prior to use of the cap 1002 and/or canprevent evaporative loss of antiseptic 1033 from the sterilizationchamber 1022.

When the cap 1002 is coupled with a medical connector, the couplingaction can bring a portion of the medical connector into contact withthe pad 1032 and can allow the pad 1032 to wipe or scrub the medicalconnector, as described above. Likewise, the antiseptic 1033 can beforced into contact with the medical connector during the coupling phaseand can remain in contact with the medical connector, while the cap 1002is coupled with the medical connector. The connection interface 1030 cancooperate with a connection interface of the medical connector tomaintain the cap 1002 in an attached configuration relative to theconnector. Moreover, the connection interface 1030 can couple with themedical connector, such as via complementary threading, so as to preventantiseptic from leaking from the sterilization chamber 1022.

In some embodiments, such as where the pad 1032 is formed of a materialthat is not fully elastically resilient or that requires a relativelylong relaxation time in which to transition from a compressed state to arelaxed or uncompressed state (e.g., in a longitudinal direction),pre-use storage in the relaxed or uncompressed state in at least onedimension can preserve or enhance the cleaning, scrubbing, orsterilization properties of the pad 1032. For example, as the cap 1002is coupled with the medical connector (e.g., the medical connector 132of FIG. 4), an end of the medical connector can come into contact with aproximal surface (e.g., the surface furthest from the partition 1020) ofthe pad 1032. Further advancement of the cap 1002 onto the medicalconnector can cause the pad 1032 to deform to complement a contour ofthe end of the medical connector as the pad 1032 is compressed, whichcan permit a relatively tight or continuous contact between the pad 1032and the medical connector. In the illustrated embodiment, the cap 1002is rotated relative to the medical connector, as it is advanced onto themedical connector. This rotational motion causes the contoured surfaceof the pad 1032 to rub the medical connector. In certain embodiments,increasingly greater compression of the pad 1032 yields increasinglystronger rubbing of the medical connector, coupled with greater amountsof the antiseptic 1033 being expelled from the pad 1032. Accordingly,when the pad 1032 is uncompressed in at least one dimension (e.g., in alongitudinal direction) in a pre-use state, and thus is not plasticallydeformed or is not subject to time-consuming elastic recovery frompre-compression, the pad 1032 can be in sanitizing contact with themedical connector for a relatively greater portion of the couplingprocedure. In some embodiments, a practitioner can more quickly couplethe cap 1002 to the medical connector, as there is no need to first waitfor the pad 1032 to relax to an uncompressed or expanded state toachieve better sterilization of the medical connector.

Various parameters can be adjusted to determine the amount of antiseptic1033 that is expelled from the pad 1032 when the cap 1002 is coupledwith a medical connector. For example, the depth to which the medicalconnector is received within the sterilization chamber 1022, theconcentration of antiseptic 1033 within the pad 1032, and/or otherparameters can be altered. In various embodiments, no less than about ¼,no less than about ⅓, no less than about ½, no less than about ⅔, or noless than about ¾ of the antiseptic 1033 is expelled from the pad 1032when the cap 1002 is coupled with a medical connector. In someembodiments, all, or substantially all, of the antiseptic 1033 isexpelled from the pad 1032.

With reference to FIG. 10, an interior surface the sidewall 1012 caninclude another connection interface 1040 in the region of the couplingchamber 1024. The connection interface 1040 can be configured tocomplementarily engage a connection interface 1042 of the cap 1004. Forexample, in the illustrated embodiment, the connection interface 1040 ofthe cap 1002 comprises inwardly projecting threads 1041, and theconnection interface 1042 of the connector 1004 comprises outwardlyprojecting threads 1043 complementary thereto at an exterior surface ofthe cap 1004. The connection interfaces 1040, 1042 thus can allow thecaps 1002, 1004 to be coupled to each other in a secure, yet selectivelyremovable fashion. Other configurations of the connection interfaces1040, 1042 may similarly permit the caps 1002, 1004 to be coupled witheach other in a secure, yet selectively removable fashion, such asfriction-fit, snap-fit, or other suitable interfacing arrangements. Thecoupling chamber 1024 can further include a sealing member 1044, such asan elastomeric gasket described further below.

With reference to FIGS. 10 and 11, the cap 1004 can comprise a housing1050. The housing 1050 can be elongated, and may define a stepped,substantially cylindrical shape, or may define any other suitable shape.For example, in the illustrated embodiment, the housing 1050 includes asidewall 1052, which is substantially cylindrical, and a base wall 1054at one end of the sidewall 1052. A sealing end 1056 of the sidewall 1052can be located opposite the base wall 1054, and can define an openinginto a sterilization chamber 1058. The sidewall 1052 and the base wall1054 thus can cooperate to define the sterilization chamber 1058.

In some embodiments, the housing 1050 includes a skirt 1060, which canextend radially outwardly from the sidewall 1052. In some embodiments,the skirt 1060 provides a convenient surface for manipulation of the cap1004. For example, in some embodiments, an outer diameter of thesidewall 1052 is smaller than an outer diameter of the sidewall 1012 ofthe cap 1002 such that the disparity between the outer diameters couldcomplicate the gripping and rotation of the caps 1002, 1004 relative toeach other. Moreover, in some embodiments, the sidewall 1052 defines arelatively small outer surface area, which could make it difficult togrip the cap 1004. The larger outer diameter and corresponding largersurface area of the skirt can facilitate gripping of the cap 1004. Theouter surface of the skirt 1060 can be smooth, as shown, or may includegripping features, which can aid in rotating the cap 1004 relative tothe cap 1002 to permit separation of the caps 1002, 1004 and/or aid inrotating the cap 1004 relative to a medical connector. Such grippingfeatures can include, for example, ridges, grooves, and/or protrusionssimilar to the ridges 105, grooves 107, and protrusions 108 describedabove and/or an elastomeric or other coating having a relatively highcoefficient of friction.

In some embodiments, a terminal edge 1062 of the skirt 1060 can besubstantially coplanar with an outer surface of the base wall 1054. Incertain of such embodiments, the skirt 1060 can increase the stabilityof the assembly 1000. For example, the assembly 1000 can stand uprightlyon the base wall 1054, and the skirt 1060 can inhibit tipping of theassembly 1000.

With reference to FIG. 10, the sterilization chamber 1058 can include apad 1070 such as the pad 1032. The pad 1070 can be deformable, so as toconform to the contours of a portion of a medical connector that isintroduced into the sterilization chamber 1058 (e.g., an outer surfaceof a male luer). Compression and/or decompression of the pad 1070 cancause an antiseptic 1033 to exit from and/or be absorbed by the pad1070, respectively, in a manner such as described above with respect tothe pad 1032 (it is noted that the antiseptic 1033 used with the pad1070 need not necessarily be the same antiseptic as that used with thepad 1032, although such is possible). Likewise, scrubbing orsanitization of a medical connector via the pad 1070 can proceed in amanner such as that described above with respect to the pad 1032. In theillustrated embodiment, the pad 1070 is in a relaxed or uncompressedstate in at least a longitudinal direction when the sterilizationchamber 1058 is in a sealed or pre-use configuration.

As previously discussed, the cap 1004 can include the connectioninterface 1042, which can interact with the connection interface 1040 ofthe cap 1002. The connection interfaces 1040, 1042 can cooperate to holdthe cap 1004 tightly against the sealing member 1044. For example, wherethe connection interfaces 1040, 1042 comprise threading, appropriaterotation of the cap 1004 relative to the cap 1002 can draw the sealingend 1056 of the sidewall 1052 into abutment with the sealing member1044, and additional rotation in the same direction may deform thesealing member 1044. The sealing end 1056 and the sealing member 1044can form a hermetic seal that can assist in maintaining the sterility ofthe sterilization chamber 1058 prior to use of the cap 1004, and canprevent evaporative loss of an antiseptic from the sterilization chamber1058. In further embodiments, a sealing tape (not shown), such as thesealing tape 158 (see FIGS. 8A and 8B), can be positioned about the caps1002, 1004 so as to contact a lower edge of the housing 1010 (e.g., anouter surface of the portion of the sidewall 1012 that defines thecoupling chamber 1058) and an outer surface of the skirt 1060 of thehousing 1050. The tape can aid in preventing evaporative loss of theantiseptic and/or can indicate whether the caps 1002, 1004 have beenseparated or otherwise moved from their initial or pre-useconfiguration. For example, in some embodiments, the tape can befrangible.

In the illustrated embodiment, the connection interface 1042 comprisesoutwardly projecting threads similar to the threads 114 described above,and can be configured to complementarily engage a connection interfaceof a medical connector, such as, for example, inwardly projectingthreads of a skirt that surrounds a male luer. The threaded connectioninterface 1042 thus can allow for selective coupling of the cap 1004 toa medical connector in a secure, yet selectively removable fashion.Other configurations of the connection interface 1042 may permit the cap1004 to be coupled with a medical connector in a secure, yet selectivelyremovable fashion, such as friction-fit, snap-fit, or other suitableinterfacing arrangements.

With continued reference to FIG. 10, additional description of theillustrated embodiment of the assembly 1000 in the pre-use state willnow be provided. As previously discussed, each sterilization chamber1022, 1058 can be defined by a separate housing 1012, 1050. The chambers1022, 1058 can be isolated from each other in the pre-use condition, orstated otherwise, no fluid communication may exist between the chambers1022, 1058.

The caps 1002, 1004 can cooperate to seal one of the chambers (e.g., thechamber 1058 in the illustrated embodiment) such that manipulation ofthe caps 1002, 1004 away from their pre-use configuration can unseal thechamber 1058, whereas the other chamber (e.g., the chamber 1022 in theillustrated embodiment) can remain in a sealed orientation independentof the relative orientations of the caps 1002, 1004. At least a portionof the housing 1050 of the cap 1004 can be received within, or can nestwithin, a portion of the housing 1010 of the cap 1002. In theillustrated embodiment, the pad 1032 is free of any compression from thecap 1004 and the pad 1070 is free of any compression from the cap 1002when the sterilization chambers 1022, 1058, in which the pads 1032, 1070are housed, are in a pre-use, sealed condition.

In the illustrated embodiment, the caps 1002, 1004 are substantiallycoaxial with each other. As previously discussed, the sterilizationchambers 1022, 1058 defined by the caps 1002, 1004 each can have an openend and a closed end, and in the pre-use configuration, the chambers1022, 1058 can be oriented such that their sealed open ends face in thesame direction along the common axis of the caps 1002, 1004.

With reference to FIG. 11, in order to prepare the cap 1004 for use witha medical connector (e.g., the connector 136 of FIG. 5), the caps 1002,1004 are decoupled from each other. For example, in the illustratedembodiment, the caps 1002, 1004 are rotated in opposite directions abouta common longitudinal axis such that the connection interfaces 1040,1042 urge the caps 1002, 1004 away from each other and are eventuallyreleased from each other. The cap 1004 can then be coupled with themedical connector via the connection interface 1042, such as in asecure, yet selectively removable manner.

The cap 1002 can be prepared for use with a medical connector (e.g., theconnector 132 of FIG. 4) and connected to the medical connectorindependent of the coupling status of the caps 1002, 1004 relative toeach other. The cover 1034 can be removed from the cap 1002, therebypermitting the cap 1002 to be coupled with the medical connector via theconnection interface 1040, such as in a secure, yet selectivelyremovable manner.

The pre-use configuration of the system 1000, in which the caps 1002,1004 are coupled with each other, can ease clinician handling of thesystem 1000. As the caps 1002, 1004 may be used to cover female and maleconnectors, respectively, immediately upon decoupling of the female andmale connectors from each other, having the caps 1002, 1004 available ina coupled yet easily separable configuration can be convenient and timesaving. Moreover, the system 1000 can include relatively few parts,which can reduce manufacturing costs. In some embodiments, the pre-usecoupled configuration of the caps 1002, 1004 likewise can reducepackaging costs of the system 1000.

FIG. 12 illustrates another embodiment of an assembly 1100, which canresemble the assembly 1000 described above in certain respects.Accordingly, like features are designated with like reference numerals,with the leading digits incremented to “11.” Relevant disclosure setforth above regarding similarly identified features thus may not berepeated hereafter. Moreover, specific features of the assembly 1100 maynot be identified by a reference numeral in the drawings or specificallydiscussed in the written description that follows. However, suchfeatures may clearly be the same, or substantially the same, as featuresdepicted in other embodiments and described with respect to suchembodiments. Accordingly, the relevant descriptions of such featuresapply equally to the features of the assembly 1100. Any suitablecombination of the features and variations of the same described withrespect to the assembly 1000 and components thereof can be employed withthe assembly 1100 and components thereof, and vice versa. This patternof disclosure applies equally to further embodiments depicted insubsequent figures and described hereafter.

As with the assembly 1000, the assembly 1100 can include a cap 1102 anda cap 1104 that are coupled with each other when in a pre-use state andthat can be removed from each other. The cap 1102 can be configured tocouple with a female connector, and the cap 1104 can be configured tocouple with a male connector. The cap 1102 can include a housing 1110,which can include a sidewall 1112 and a partition 1120. A portion of thesidewall 1112 can cooperate with the partition 1120 to define asterilization chamber 1122 such as the sterilization chamber 1022. Inthe illustrated embodiment, the sterilization chamber 1122 is somewhatshorter than the sterilization chamber 1022 (see FIG. 10). Thesterilization chamber 1122 can include a connection interface 1130,which, in the illustrated embodiment, includes threading 1131. Thesterilization chamber 1122 can include a pad 1132, such as the pad 1032,and can be sealed via a removable cover 1134.

Another portion of the sidewall 1112 can cooperate with the partition1120 to define a coupling chamber 1124 that extends in a directionopposite the sterilization chamber 1122. A terminal edge 1118 of thesidewall 1112 can define an opening of the sterilization chamber 1122.The sidewall 1112 can define a connection interface 1140 that isconfigured to aid in coupling the caps 1102, 1104 with each other, asdescribed further below.

With continued reference to FIG. 12, the cap 1104 can include a housing1150 that includes a sidewall 1152 and a base wall 1154. The sidewall1152 and the base wall 1154 can cooperate to define a sterilizationchamber 1158, which can include a pad 1170 therein. The sterilizationchamber 1158 can be sealed at a sealing end 1156 of the sidewall 1152via a removable cover 1136, which can resemble the cover 1134. A portionof the sidewall 1152 can define a connection interface 1142, whichincludes one or more threads 1143 in the illustrated embodiment.

The housing 1150 can define a skirt 1160 that projects radiallyoutwardly from the sidewall 1152. The skirt 1160 can terminate at aterminal edge 1162. In the illustrated embodiment, the skirt 1160 isshorter than the skirt 1060 of the housing 1050 (see FIG. 10) and isspaced above a plane that is defined by an outer surface of the basewall 1154. In some embodiments, the terminal edge 1162 contacts or is inclose proximity to the terminal edge 1118 of the housing 1110 when thecaps 1102, 1104 are coupled with each other in a pre-use configuration,which can provide continuity to an outer surface of the assembly 1100when it is in a pre-use configuration. The skirt 1160 can be rounded orbeveled at the terminal edge 1162, and an end of the sidewall 1112 canbe rounded or beveled at the terminal edge 1118, which can provide thesystem 1100 with an annular recess 1163 that can provide a visual and/ortactile indication of the transition from the skirt 1160 to the sidewall1112. The rounded ends can also enhance practitioner and/or patientcomfort during use of the caps 1102, 1104.

In the illustrated embodiment, the sidewall 1152 of the housing 1150defines a connection interface 1180 that is configured to couple withthe connection interface 1140 of the housing 1110. In particular, theconnection interface 1180 includes an outward projection 1181 and theconnection interface 1140 includes a recess 1144 that extends radiallyoutwardly relative to the connection chamber 1124 and that is sized toreceive the annular projection 1181 therein in a snap-fit engagement. Inthe illustrated embodiment, each of the projection 1181 and the recess1144 is annular and extends about the cap 1104 and the cap 1102,respectively, in its entirety. In other embodiments, the projection 1181and/or the recess 1144 extend about only a portion of the caps 1102,1104. In still other or further embodiments, the connection interface1180 can include a recess in the sidewall 1152 and the connectioninterface 1140 can include an inward projection sized to fit within therecess in a snap-fit engagement. In still other or further embodiments,the connection interfaces 1140, 1180 can include complementarythreading, such as the connection interfaces 1040, 1042 described above.Other coupling arrangements are also possible.

Features, usage, and operation of the assembly 1100 can resemble that ofthe assembly 1000 described above. For example, when the assembly 1100is in the pre-use condition, each sterilization chamber 1122, 1158 canbe defined by a separate housing 1112, 1150, and the sterilizationchambers 1122, 1158 can be fluidly isolated from one another (e.g., nofluid communication may exist between the sterilization chambers 1122,1158). Likewise, at least a portion of the housing 1150 of the cap 1104can be received within, or can nest within, a portion of the housing1110 of the cap 1102. In the illustrated embodiment, each of the pads1132, 1170 is in an uncompressed or expanded state when each of thesterilization chambers 1122, 1158 in which it is housed is in a pre-use,sealed condition.

However, certain differences can exist between the assembly 1100 and theassembly 1000. For example, each of the sterilization chambers 1122,1158 can remain sealed independent of the coupling status of the caps1102, 1104. Stated otherwise, the caps 1102, 1104 do not cooperate toseal either of the chambers 1122, 1158. Accordingly, one or both of thecaps 1102, 1104 can be unsealed (e.g., the covers 1134, 1136 can beremoved) and coupled with a separate medical connector (e.g., via theconnection interfaces 1130, 1142) without detaching the caps 1102, 1104from each other. Stated in yet another manner, either of the caps 1102,1104 can be installed on a medical connector without being detached fromand/or without unsealing the other cap 1102, 1104. Alternatively, thecaps 1102, 1104 can be detached from each other, one or both of the caps1102, 1104 each can be connected with a separate medical connector(i.e., via the connection interfaces 1130, 1142), and the caps 1102,1104 can be reattached to each other (i.e., via the connectioninterfaces 1140, 1180), while remaining connected to the one or moremedical connectors.

Moreover, in the illustrated embodiment, the caps 1102, 1104 aresubstantially coaxial with each other, thus resembling the caps 1002,1004. However, the sterilization chambers 1122, 1158 are oriented suchthat their sealed open ends face away from each other (e.g., outwardlyin opposite directions) along the common axis of the caps 1102, 1104,when the assembly 1100 is in the pre-use configuration.

FIG. 13 illustrates another embodiment of an assembly 1200, which canresemble one or more of the assemblies described above in certainrespects. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “12.” As with theassembly 1100, the assembly 1200 can include a cap 1202 and cap 1204that are coupled with each other, when in a pre-use state, and that canbe removed from each other.

The caps 1202, 1204 can differ from the caps 1102, 1104 in the manner bywhich they are coupled with each other. In particular, the cap 1202includes a housing 1210 that defines a connection chamber 1224configured to receive a portion of a housing 1250 of the cap 1204. Thehousing 1210 defines a connection interface 1240, and the housing 1250defines a connection interface 1280. Rather than cooperating in asnap-fit engagement, however, the connection interfaces 1240, 1280cooperate with each other in a friction-fit engagement to provide asecure attachment between the caps 1202, 1204 and yet to permit the caps1202, 1204 to be selectively removable from each other and to permitselective reattachment of the caps 1202, 1204 to each other. Features,usage, and operation of the assembly 1200 can otherwise resemble that ofthe assembly 1100 described above.

FIGS. 14 and 15 illustrate another embodiment of an assembly 1300, whichcan resemble one or more of the assemblies described above in certainrespects. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “13.” The assembly 1300can include a cap 1302 and cap 1304 that are coupled with each otherwhen in a pre-use state and that can be removed from each other.However, as discussed further below, the caps 1302, 1304 can includeconnection interfaces 1340, 1380, respectively, that attach the caps1302, 1304 to each other in a pre-use configuration, and that permitready detachment of the caps 1302, 1304 one from another, but that donot themselves permit reattachment of the caps 1302, 1304.

The cap 1302 can include a housing 1310, which can include a sidewall1312 and a base wall 1313. The sidewall 1312 and the base wall 1313 cancooperate to define a sterilization chamber 1322 that can include a pad1332 therein and that can be sealed via a removable cover 1334. The basewall 1313 can include a terminal surface 1318 and can define theconnection interface 1340. In the illustrated embodiment, the connectioninterface 1340 includes a depression or recess 1345 that bows theterminal surface 1318 inwardly, or toward the sterilization chamber1322. The connection interface 1340 further includes a pin 1346 thatextends outwardly, or away from the sterilization chamber 1322.

With continued reference to FIGS. 14 and 15, the cap 1304 can include ahousing 1350 that includes a sidewall 1352 and a base wall 1354. Thesidewall 1352 and the base wall 1354 can cooperate to define asterilization chamber 1358, which can include a pad 1370 therein. Thesterilization chamber 1358 can be sealed via a removable cover 1336. Aportion of the sidewall 1352 can define a connection interface 1342,which includes one or more threads 1343 in the illustrated embodiment.

The housing 1350 can define a skirt 1360 that projects radiallyoutwardly from the sidewall 1352. The skirt 1360 can terminate at aterminal edge 1362. In the illustrated embodiment, the skirt 1360extends past a plane that is defined by an outer surface of the basewall 1354 and is sufficiently long to permit the terminal edge 1362thereof to contact the terminal surface 1318 of the housing 1310 whenthe caps 1302, 1304 are in a pre-use configuration. As with the skirt1160 and the sidewall 1112, the skirt 1360 can be rounded or beveled atits terminal edge 1362, and the sidewall 1112 can be rounded or beveledat the terminal surface 1118, which can provide the system 1300 with anannular recess 1363.

The housing 1350 defines the connection interface 1380, which isconfigured to couple with the connection interface 1340 of the housing1310. The connection interface 1380 includes a protrusion 1382 thatextends from the base wall 1354 in a direction opposite thesterilization chamber 1358. The protrusion 1382 is sized and shaped toreceive therein at least a portion of the pin 1346, and may besubstantially annular. In various embodiments, the protrusion 1382 isjoined to the pin in any suitable manner, such as, for example,press-fit or friction-fit engagement and/or any suitable adhesive.

In the illustrated embodiment, an additional protrusion 1384 is coaxialwith and encircles the protrusion 1382, and may also be substantiallyannular. The protrusion 1384 can contact the terminal surface 1318 ofthe housing 1310 when the caps 1302, 1304 are in a pre-useconfiguration, and can provide stability to the connection interfaces1340, 1380 and assist in preventing premature separation of the caps1302, 1304. The protrusion 1384 can be said to define a connectionchamber 1324 in which the connection interface 1380 is located.

As shown in FIG. 15, the caps 1302, 1304 can be separated from eachother, which can facilitate coupling of the caps 1302, 1304 to separatemedical connectors by removing a constraint on the range of motion ofthe caps 1302, 1304 relative to each other. In the illustratedembodiment, the pin 1346 can be sufficiently thin, sufficiently weak, orotherwise configured to break away from the housing 1310, and can remainattached to the protrusion 1382 of the housing 1350. In variousembodiments, in order to break the pin 1346, a practitioner can rotatethe caps 1302, 1304 relative to each other about their commonlongitudinal axis and/or can rotate one or more of the caps 1302, 1304about an axis perpendicular to its longitudinal axis so as to move thelongitudinal axes of the caps 1302, 1304 out of alignment with eachother.

Breaking the pin 1346 can leave a nub 1347 on the housing 1310. Incertain embodiments, the nub 1347 can be fully below the terminalsurface 1318 of the housing 1310 due to the recess 1345, which canprevent or reduce contact with the nub 1347, such as by a patient orpractitioner.

In certain embodiments, the connection interfaces 1340, 1380 areconfigured so as to not rejoin with each other once the caps 1302, 1304have been separated from the pre-use configuration. For example, oncethe pin 1346 has been broken, the caps 1302, 1304 cannot readily berejoined to each other via the pin 1346. Accordingly, the caps 1302,1304 can be configured to be attached with each other in a pre-useconfiguration and readily separated from each other as desired, but notreadily rejoined with each other once separated.

Features, usage, and operation of the assembly 1300 can resemble thoseof one or more of the assemblies described above in other respects. Forexample, when the assembly 1300 is in the pre-use condition, eachsterilization chamber 1322, 1358 can be defined by a separate housing1312, 1350, and the sterilization chambers 1322, 1358 can be fluidlyisolated from one another. Likewise, at least a portion of one of thehousings 1310, 1350 can be received within, or can nest within, aportion of the other housing 1310, 1350. To this end, it is noted thatin other embodiments of the assembly 1300, the housing 1350 of the cap1304 may define the pin 1346 (or, more generally, the connectioninterface 1340), and the housing 1310 of the cap 1302 may define theannular extension 1382 (or, more generally, the connection interface1380). In the illustrated embodiment, each of the pads 1332, 1370 is inan uncompressed or expanded state when the sterilization chamber 1322,1358 in which it is housed is in a pre-use, sealed condition. Like theassemblies 1100, 1200, each of the sterilization chambers 1322, 1358 canremain sealed independent of the coupling status of the caps 1302, 1304.One or both of the sterilization chambers 1322, 1358 can be opened andused, while the caps 1302, 1304 are connected with each other, or thecaps 1302, 1304 can be separated from each other and one or both of thesterilization chambers 1322, 1358 can then be opened and each used witha separate medical connector.

FIGS. 16 and 17 illustrate another embodiment of an assembly 1400, whichcan resemble the assembly 1300 described above in certain respects.Accordingly, like features are designated with like reference numerals,with the leading digits incremented to “14.” The assembly 1400 caninclude a cap 1402 and cap 1404 that are coupled with each other when ina pre-use state, and that can be removed from each other in a mannersimilar to the caps 1302, 1304. However, connection interfaces 1440,1480 of the caps differ from the connection interfaces 1340, 1380 of thecaps 1302, 1304.

The connection interface 1440 can be defined by a terminal surface 1418of a housing 1410 of the cap 1402. The connection interface 1440 caninclude a depression or recess 1448 that bows the terminal surface 1418inwardly, or toward a sterilization chamber 1422. The recess 1448 can beannular, although other shapes and configurations are possible.

A sidewall 1452 of the cap 1404 can be somewhat longer than the sidewall1352 of the cap 1304, and a base wall 1454 of the cap 1404 can be inclose proximity with or adjacent to the terminal surface 1418 of the cap1402. A protrusion 1485 can extend outwardly from the base wall 1454, orin a direction away from a sterilization chamber 1458. The protrusion1485 can be annular so as to be received within the annular recess 1448,although other shapes and configurations are possible. The protrusion1485 can be joined to the recess 1448 in any suitable manner, such asvia an adhesive or via welding (e.g., spin, ultra-sonic, laser, radiofrequency, thermal, etc.).

In the illustrated embodiment, the protrusion 1485 is welded to therecess 1448, and the weld is configured to be broken to permitseparation of the caps 1402, 1404. As shown in FIG. 17, a weld edge 1486can remain within the recess 1448 when the caps 1402, 1404 areseparated. In certain embodiments, the weld edge 1486 can be fully belowthe terminal surface 1418 of the housing 1410, which can prevent orreduce contact with the weld edge 1486, such as by a patient orpractitioner. In order to break the weld, a practitioner can rotate thecaps 1402, 1404 relative to each other about their common longitudinalaxis and/or can rotate one or more of the caps 1402, 1404 about an axisperpendicular to its longitudinal axis, so as to move the longitudinalaxes of the caps 1402, 1404 out of alignment with each other. In otherembodiments, the connection interfaces 1440, 1480 can be reversed suchthat the cap 1402 includes the protrusion 1485 and the cap 1404 canincludes the recess 1448.

FIGS. 18-21 illustrate another embodiment of an assembly 1500, which canresemble one or more of the assemblies described above in certainrespects. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “15.” As can be seen inFIGS. 18 and 19, and as discussed hereafter, the assembly 1500 caninclude a cap 1502 and cap 1504 that are coupled with each other when ina pre-use state and that can be removed from each other. The cap 1502can be configured to couple with a female connector, and the cap 1504can be configured to couple with a male connector. The caps 1502, 1504can be in a side-by-side arrangement when connected to each other in apre-use configuration. In the illustrated embodiment, both caps 1502,1504 can be sealed shut in the pre-use configuration via a common cover1537.

The cap 1502 can include a housing 1510, which can include a sidewall1512 and a base wall 1513. The sidewall 1512 can cooperate with the basewall 1513 to define a sterilization chamber 1522. The sterilizationchamber 1522 can include a connection interface 1530, which, in theillustrated embodiment, includes threading 1531 disposed on an interiorsurface of the housing 1512. The connection interface 1530 can beconfigured to attach the cap 1502 to a medical connector in a secure yetselectively removable manner. The sterilization chamber 1522 can includea pad 1532.

The housing 1510 can further include a skirt 1561 that projects radiallyoutwardly from the sidewall 1512 and that can also extend substantiallyparallel to the sidewall 1512. The skirt 1561 can include one or morespacers or supports 1564 that can provide structural rigidity to theskirt 1561. As shown in FIGS. 19 and 21, the housing 1510 can define aconnection interface 1540 that is configured to aid in coupling the caps1502, 1504 with each other in a pre-use configuration, as discussedfurther below. The connection interface 1540 can include a slot 1548defined by the skirt 1561, which can extend in a direction substantiallyparallel to a longitudinal axis of the sterilization chamber 1522. Thesidewall 1512 and the skirt 1561 can cooperate to define an openconnection chamber 1524, which is also discussed below. The slot 1548can define a side opening of the connection chamber 1524.

With reference to FIGS. 19 and 20, the cap 1504 can include a housing1550 that includes a sidewall 1552 and a base wall 1554. The sidewall1552 and the base wall 1554 can cooperate to define a sterilizationchamber 1558, which can include a pad 1570 therein. A portion of thesidewall 1552 can define a connection interface 1542, which includes oneor more threads 1543 in the illustrated embodiment. The connectioninterface 1542 can be configured to attach the cap 1504 to a medicalconnector in a secure yet selectively removable manner. The housing 1550can define a skirt 1560 that projects radially outwardly from thesidewall 1552 and that can also extend substantially parallel to thesidewall 1552. In the illustrated embodiment, the skirt 1560 extendsabout only a portion of the cap 1504. The skirt 1560 can include one ormore spacers or supports 1565 that can provide structural rigidity tothe skirt 1560.

The housing 1550 can further define a connection interface 1580 that isconfigured to interact with the connection interface 1540 of the housing1510 to couple the caps 1502, 1504. The connection interfaces 1540 canmaintain the caps 1502, 1504 in a pre-use configuration, and can permitthe caps 1502, 1504 to be selectively removed from this configuration.In the illustrated embodiment, the connection interfaces 1540, 1580 canfurther interact with each other to permit selective reattachment of thecaps 1502, 1504 to each other.

In the illustrated embodiment, the connection interface 1580 includes alocking member, snapping member, or radial extension 1585. The extension1585 projects radially from the sidewall 1552 and includes an enlargedregion at its outermost end. The extension 1585 is configured to bereceived within the slot 1548 and the connection chamber 1524 of the cap1502. The enlarged portion of the extension 1585 can prevent theextension 1585 from moving out of the slot 1548 in a lateral direction.Although not shown, in some embodiments, the slot 1548 and the extension1585 can include keying, such as a protrusion and recess that cooperatein a snapping fashion, which can selectively prevent the extension 1585from moving out of the slot 1548 in a longitudinal direction in theabsence of application of sufficient force by a practitioner. In otherembodiments, the connection interfaces 1540, 1580 can be reversed suchthat the cap 1402 includes the extension 1585 and the cap 1504 includesthe slot 1548.

In the illustrated embodiment, a terminal surface 1518 of the cap 1502and a terminal surface 1562 of the cap 1504 are substantially coplanarwhen the system 1500 is in the pre-use configuration. This cancontribute to the stability of the pre-use system 1500, as the connectedsystem 1500 can be set on a planar surface without a predisposition totipping. Likewise, in the illustrated embodiment, a sealing end 1516 ofthe cap 1502 and a sealing end 1556 of the cap 1504 are substantiallycoplanar when the system 1500 is in the pre-use configuration. Eachsealing end 1516, 1556 can be sealed closed via a single or commonremovable cover 1537. In the illustrated embodiment, the cover 1537includes two tabs 1538 that can permit selective opening of just one ofthe caps 1502, 1504, or the opening both of the caps 1502, 1504 bybeginning with opening one of the caps 1502, 1504 by removing a portionof the cover 1537 from that cap 1502, 1504 and then continuing to removethe cover 1537 from the remaining cap 1502, 1504. Other arrangements arealso possible.

The cover 1537 can assist in maintaining the caps 1502, 1504 coupledwith each other in the pre-use configuration, as it can be sufficientlytight to resist longitudinal movement of the caps 1502, 1504 relative toeach other. In various embodiments, the cover 1537 is removed from oneor both of the caps 1502, 1504 prior to removing the caps 1502, 1504from each other, as shown in FIG. 19. In other embodiments, theconnection interfaces 1540, 1580 of the caps 1502, 1504 can be decoupledfrom each other prior to removing the cover 1537.

Features, usage, and operation of the assembly 1500 can resemble that ofone or more of the assemblies described above. For example, when theassembly 1500 is in the pre-use condition, each sterilization chamber1522, 1558 can be defined by a separate housing 1512, 1550, and thesterilization chambers 1522, 1558 can be fluidly isolated from oneanother. Likewise, at least a portion of the housing 1550 of the cap1504 can be received within, or can nest within, a portion of thehousing 1510 of the cap 1502. In the illustrated embodiment, each of thepads 1532, 1570 is in an uncompressed or expanded state when thesterilization chamber 1522, 1558 in which it is housed is in a pre-use,sealed condition.

However, certain differences can exist. For example, in the illustratedembodiment, the caps 1502, 1504 are side-by-side, rather than coaxial,when in the pre-use configuration. Stated otherwise, each cap 1502, 1504can define a longitudinal axis, and the longitudinal axes can besubstantially parallel with each other or non-collinear relative to eachother when the caps 1502, 1504 are in the pre-use configuration. In theillustrated embodiment, the sterilization chambers 1522, 1558 areoriented such that their sealed open ends face in substantially the samedirection when the assembly 1500 is in the pre-use configuration.

FIG. 22 illustrates another embodiment of an assembly 1600, which canresemble one or more of the assemblies described above, particularly theassembly 1500, in certain respects. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “16.” The assembly 1600 can include caps 1602, 1604 suchas the caps 1502, 1504. Rather than including a single cover 1537,however, an individual cover 1634, 1636 is provided to each of the caps1602, 1604. Such an arrangement can, in some instances, facilitateremoval of the caps 1602, 1604 from each other while the caps 1602, 1604are maintained in a sealed configuration.

FIG. 23 illustrates an embodiment of a cap 1702 that can be used in theplace of the caps 1502, 1602 in the systems 1500, 1600. The cap 1702 caninclude a housing 1710 that includes a sidewall 1712 and a skirt 1761.The sidewall 1712 can taper radially outwardly with increasing distancefrom the skirt 1761. Moreover, the housing 1710 can include an extensionregion 1717 that projects in an opposite direction from the skirt 1761.The extension region 1717 can include a rounded terminal surface 1718.The cap 1702 thus can more closely resemble the cap 102 described above.For example, the extension region 1717 can include gripping features1703, such as ridges 1705 and grooves 1707. Similar alterations can bemade to the caps 1504, 1604.

FIG. 24 illustrates another embodiment of an assembly 1800, which canresemble one or more of the assemblies described above in certainrespects. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “18.” The assembly 1800can include a cap 1802 and cap 1804 that are coupled with each otherwhen in a pre-use state and that can be removed from each other. Inparticular, the caps 1802, 1804 can be coupled with each other via asealing mechanism. In the illustrated embodiment, the caps 1802, 1804are coupled with each other via a sealing sleeve 1890. The caps 1802,1804 can have open ends facing one another, and sterilization chambers1822, 1858 of the caps 1802, 1804 can be in fluid communication witheach other, when in the pre-use configuration.

The cap 1802 can include a housing 1810, which can include a sidewall1812 and a base wall 1813. The sidewall 1812 can cooperate with the basewall 1813 to define the sterilization chamber 1822. The sterilizationchamber 1822 can include a connection interface 1830, which, in theillustrated embodiment, includes threading 1831 disposed on an interiorsurface of the housing 1812. The connection interface 1830 can beconfigured to attach the cap 1802 to a medical connector in a secure yetselectively removable manner. The sterilization chamber 1822 can includea pad 1832.

An exterior surface of the sidewall 1812 can define a connectioninterface 1840 that is configured to couple the cap 1802 with aconnection interface 1891 of the sleeve 1890. In the illustratedembodiment, the connection interfaces 1840, 1891 couple with each othervia a friction-fit engagement. The friction fit can be sufficientlystrong to provide a fluid-tight seal between the cap 1802 and the sleeve1890, yet can allow the cap 1802 to be removed from the sleeve 1890 viamere manipulation by a medical practitioner (e.g., without the use ofancillary tools). The fluid-tight seal can prevent evaporative loss ofantiseptic from the pad 1832 and/or can maintain the sterility of thesterilization chamber 1822. In other or further embodiments, theconnection interfaces 1840, 1891 can include threading or other suitableattachment features.

In the illustrated embodiment, the base wall 1813 protrudes slightlybeyond an end of the sleeve 1890, which can aid in manipulating the cap1802 away from the sleeve 1890. In other embodiments, the base wall 1813can protrude even further, or can include one or more protrusions orgripping features, that can aid in removing the cap 1802 from the sleeve1890.

The cap 1802 can include a flange 1815 having an outer diameter largerthan an inner diameter of the end of the sleeve 1890 that connects withthe cap 1802. The flange 1815 can prevent the cap 1802 from beinginserted into the sleeve 1890 too deeply. In other or furtherembodiments, the flange 1815 can cooperate with an end surface of thesleeve 1890 to create a liquid-tight seal. For example, in someembodiments, a sealing member, such as an “O” ring, is included betweenthe flange 1815 and the end of the sleeve 1890 to provide theliquid-tight seal.

The cap 1804 can include a housing 1850 that includes a sidewall 1852and a base wall 1854. The sidewall 1852 and the base wall 1854 cancooperate to define a sterilization chamber 1858, which can include apad 1870 therein. A portion of the sidewall 1852 can define a connectioninterface 1842, which includes one or more threads 1843 in theillustrated embodiment. The connection interface 1842 can be configuredto attach the cap 1804 to a medical connector in a secure yetselectively removable manner. Additionally, the connection interface1842 can cooperate with a connection interface 1892 defined by thesleeve 1890 to couple the cap 1804 with the cap 1802. The connectioninterface 1892 can include threading 1893 that is complementary to thethreading 1843. The interfaces 1842, 1892, when coupled with each other,can provide a fluid-tight seal between the cap 1804 and the sleeve 1890.In other embodiments, the connection interfaces 1842, 1890 can insteaddefine a friction-fit seal, such as that provided by the illustratedembodiment of the connection interfaces 1840, 1891 described above. Instill other or further embodiments, a flange 1859 defined by the housing1850 can cooperate with an end surface of the sleeve 1890 to create aliquid-tight seal, which can prevent evaporative loss of antiseptic fromthe pad 1870 and/or maintain the sterility of the sterilization chamber1858. For example, in some embodiments, a sealing member, such as an “O”ring, is included between the flange 1859 and the end of the sleeve 1890to provide the liquid-tight seal.

Features, usage, and operation of the assembly 1800 can resemble that ofone or more of the assemblies described above. For example, when theassembly 1800 is in the pre-use condition, each sterilization chamber1822, 1858 can be defined by a separate housing 1812, 1850. Likewise,the caps 1802, 1804 can be coaxial with each other, and the open ends ofthe caps 1802, 1804 can face in opposite directions (e.g., towards eachother). In the illustrated embodiment, each of the pads 1832, 1870 is inan uncompressed or expanded state when the sterilization chamber 1822,1858 in which it is housed is in a pre-use, sealed condition.

However, certain differences can exist. For example, in the illustratedembodiment, the sterilization chambers 1822, 1858 are in fluidcommunication with each other when the caps 1802, 1804 are in thepre-use state. Moreover, in the illustrated embodiment, no portion ofthe housing 1850 of the cap 1804 is received within, or nested within,any portion of the housing 1810 of the cap 1802.

FIGS. 25-29 illustrate another embodiment of an assembly 1900, which canresemble one or more of the assemblies described above in certainrespects. Accordingly, like features are designated with like referencenumerals, with the leading digits incremented to “19.” As shown, forexample, FIGS. 25 and 26, the assembly 1900 can include a male capportion or cap 1902 and a female cap portion or cap 1904 that areintegrally formed or otherwise permanently attached with each other. Forexample, the caps 1902, 1904 can include a single, integrally moldedhousing 1910. The cap 1902 can be configured to couple with a femaleconnector, and the cap 1904 can be configured to couple with a maleconnector. In the illustrated embodiment, the caps 1902, 1904 are in acoaxial arrangement. As shown, for example, in FIGS. 26 and 28, theassembly 1900 can include a pad 1970 that is received within one or moreof the caps 1902, 1904. As shown, for example, in FIGS. 25 and 26, eachcap 1902, 1904 can be sealed shut in the pre-use configuration via aseparate cover 1934, 1938, respectively. Each cover 1934, 1938 caninclude a tab 1935, 1939, respectively, that can aid in removal of thecover.

With continued reference to FIGS. 25-29, the housing 1910 can define atleast a portion of each of the caps 1902, 1904. The housing 1910includes a first sidewall 1912 that defines a first sterilizationchamber 1922 and includes a second sidewall 1952 that defines a secondsterilization chamber 1958. As shown in FIG. 29, the first sidewall 1912can define larger inner and outer diameters than those defined by thesecond sidewall 1952. The housing 1910 can transition from the firstsidewall 1912 and the first sterilization chamber 1922 to the secondsidewall 1952 and the second sterilization chamber 1958 at aconstriction or abutment 1920. The housing 1910 can be substantiallyhollow such that the first and second sterilization chambers 1922, 1958are in fluid communication with each other. The housing 1910 can defineanother abutment 1921, which is discussed further below.

As shown in FIGS. 26, 28, and 29, the male cap 1902 can include aconnection interface 1930 that is configured to couple with a connectioninterface of a medical connector, such as a needleless injection site.The connection interface 1930 can include threading 1931, which can bedisposed at an interior of the sidewall 1912. In some embodiments, themale cap 1902 includes one or more gripping features 1903 at an exteriorsurface of the sidewall 1912. In the illustrated embodiment, thegripping features 1903 are raised areas. In other embodiments, thegripping features 1903 can include depressed areas. The grippingfeatures 1903 can be formed in the shape of a company logo or any othersuitable shape.

As shown in FIGS. 26, 27, and 29, the female cap 1904 can include aconnection interface 1942 that is configured to couple with a connectioninterface of a medical connector, such as a medical attachment having amale luer. The connection interface 1942 can include threading 1943,which can be disposed at an exterior surface of the sidewall 1952. Thecap 1904 can include one or more vents 1959, which can be located at anend of the sidewall 1952. The one or more vents can also extend alongthe length of sidewall 1952. In the illustrated embodiment, aconstriction, rim, or lip 1953 projects radially inwardly at the end ofthe sidewall 1952, which can aid in maintaining the pad 1970 within thecap 1904. In particular, the lip 1953 can define a smaller innerdiameter than an outer diameter of the pad 1970 (see FIG. 29). The vents1959 can comprise notches in the lip 1953. The illustrated embodimentincludes four vents 1959, although more or fewer vents are possible.

With reference to FIG. 26, the pad 1970 can define a shape generallyresembling a series of tiered cylinders. A rim 1971 can extendtransversely, or radially outwardly, from a cylinder that has thesmallest diameter. Another rim 1972 can extend transversely from acylinder having an intermediate diameter. The largest cylinder can havea recess 1973 disposed therein. In certain embodiments, such as theillustrated embodiment, one or more extensions 1974 protrude from an endof the pad 1970 in a longitudinal direction. Each extension 1974 caninclude a groove 1975 therein, as discussed further below. In otherembodiments, the one or more extensions 1974 are omitted.

With reference to FIG. 29, the pad 1970 can be secured within thehousing 1910 in any suitable manner, and thus can resist translationalmovement in either direction that would cause the pad 1970 to exit thehousing 1910 from either open end of the housing. For example, in theillustrated embodiment, interaction of the threads 1931 with a left endof the pad 1970 can prevent the pad 1970 from moving out of the housing1910 in a leftward direction as a portion of a medical connector (e.g.,a male luer connector) is inserted into the housing 1910 from the right.As shown in FIG. 29, some portions of the pad 1970 can be compressed bythe threads 1931, whereas the grooves 1975 of the extensions 1974 canaccommodate the threads 1931. The enlarged tiered sections of the pad1970, and the resultant interaction of the rims 1971, 1972 with theabutments 1920, 1921, respectively, can prevent the pad 1970 from movingout of the housing 1910 in the rightward direction as a portion of amedical connector (e.g., a needleless injection site) is advanced intothe housing 1920 from the left. In other or further embodiments, the pad1970 can be adhered to the housing 1910.

With reference to FIGS. 26 and 27, the cover 1938 can be secured to thehousing 1910 in any suitable manner. For example, in some embodiments,an end of the cover 1938 is adhered or otherwise sealed to a sealingsurface 1956 at an end of the sidewall 1952 so as to provide a hermeticseal. A side portion of the cover 1938 thus can cover the connectioninterface 1942 of the cap 1904. In other or further embodiments, a lowercircumferential edge of the cover 1938 can be adhered or otherwisesealed to a sealing surface 1957 at a base end of the sidewall 1952 soas to provide a hermetic seal. With reference to FIGS. 26 and 28, thecover 1934 can be adhered or otherwise sealed to a sealing surface 1916at an end of the sidewall 1912 of the housing 1910.

FIG. 30 illustrates an early stage of the coupling of a medicalconnector 2000 with the cap 1904. The medical connector 2000 can includea housing 2005 that complies with ISO standards (e.g., ISO 594-1:1986and ISO 594-2:1998). The housing 2005 can include a skirt 2010 thatdefines a connection interface 2012, which itself can include threading2014. The housing 2005 can also include a male luer 2020, which candefine a fluid passageway 2022.

In the illustrated embodiment, a tip of the male luer 2020 can contactan end surface of the pad 1970 prior to engagement of the connectioninterfaces 1942, 2012 (e.g., the threadings 1943, 2014) with each other.Accordingly, some compression of the pad 1970 may occur withoutassistance from the connection interfaces 1942, 2012. In otherembodiments, the connection interfaces 1942, 2012 may engage one anotherprior to contact being made between the tip of the male luer 2020 andthe end surface of the pad 1970, such as may occur when the pad 1970 ismore recessed within the housing 1910 and/or the skirt 2010 and itsconnection interface 2012 are longer. In either case, in someembodiments, the connection interfaces 1942, 2012 can assist in thecompression of the pad 1970. The desired antiseptic concentration levelof the pad 1970 is determined by the volume required to fully coat andsterilize the medical connector 2000, while taking into considerationthe evaporative loss that may occur during the shelf life of cap 1904.

FIG. 31 illustrates a later stage of the coupling of the medicalconnector 2000 with the cap 1904. As the male luer 2020 is advanced intothe sterilization chamber 1958 of the cap 1904, it compresses the pad1970 and causes antiseptic 1933 to egress therefrom. The pad 1970 canremain relatively fixed, rotationally, while the male luer 2020 isrotated and advanced further into the chamber 1958, which can effect arubbing or scrubbing of the tip of the luer 2020, particularly asincreased compression of the pad 1970 provides an increased force of thepad 1970 against the tip. The released antiseptic can fill an opening orvolume of space between the sidewall 1952 of the housing 1910 and anouter surface of the male luer 2020, and can thereby sterilize the outersurface of the male luer 2020. Additionally, in the illustratedembodiment, the fluid passageway 2022 of the male luer 2020 is open suchthat antiseptic fluid 1933 may enter into it.

In certain embodiments, a seal can form between the lip 1953 and themale luer 2020 when the luer 2020 is advanced sufficiently far into thechamber 1958. The seal thus formed can be an interrupted seal, such thatthe seal is formed only at those regions where the luer 2020 and the lip1953 are in contact with each other. Antiseptic 1933 can be permitted toexit from the chamber 1958 via the vents 1959. In some embodiments, thevents 1959 are sufficiently large to permit antiseptic 1933 to exit fromthe chamber 1958 freely once the antiseptic 1933 has been expelled fromthe pad 1970. Antiseptic 1933 that exits from the chamber 1958 throughthe vents 1959 can sterilize portions of the male luer 2020 that areproximal of the lip 1953.

In other embodiments, the vents 1959 are sufficiently small to preventantiseptic 1953 from exiting from the chamber 1958 when a pressurewithin the chamber 1958 is the same or approximately the same as apressure outside of the chamber 1958 (e.g., atmospheric pressure), andyet are sufficiently large to permit antiseptic 1933 to exit the chamber1958 when the pressure within the chamber 1958 is significantly greaterthan the pressure outside of the chamber 1958, such as may result whenthe luer 2020 is being advanced deeper within the chamber 1958. Thevents 1959 thus can permit selective egress of the antiseptic 1933 toaid in achieving the desired positioning of the male luer 2020, yet canmaintain the antiseptic 1933 within the chamber 1958 in order to bathe aportion of the male luer 2020 once the male luer 2020 is positioned asdesired. In still other embodiments, a fluid-tight seal is formedbetween the lip 1953 and the male luer 2020.

In certain embodiments, the pad 1970 may be recessed within the chamber1958 to a greater degree when in the uncompressed state (e.g., when inthe state shown in FIG. 30). Moreover, the threads 2014 of theconnection interface 2012 and the threads 1943 of the connectioninterface 1942 can permit the antiseptic 1933 to pass through them, soas to provide additional venting of the chamber 1958. For example,threaded connection interfaces 2012, 1942 can permit antiseptic 1933that has exited from the chamber 1958 to spiral about an outer surfaceof the second sidewall 1952 in a distal direction.

Each of FIGS. 32-34 illustrates the cap 1902 coupled with a separateneedleless injection site 2040, 2060, 2080. As with other caps disclosedherein, the cap 1902 can be versatile so as to couple with a variety ofdifferent types of medical connectors in a secure fashion thatsterilizes each type of medical connector. As can be seen in each ofFIGS. 32-34, coupling of the needleless injection sites 2040, 2060, 2080with the cap 1902 can effect compression of one end of the pad 1970 in amanner similar to that described above with respect to compression ofthe other end of the pad 1970. Compression of the pad 1970 and rotationof the needleless injection site 2040, 2060, 2080 can effect rubbing,swabbing, or scrubbing of the needleless injection site andsterilization thereof via the antiseptic 1933.

With reference to FIG. 32, the needleless injection site 2040 cancomprise a Clave® port available from ICU Medical, Inc. The needlelessinjection site 2040 can include a housing 2042 that defines a connectioninterface 2044. The needleless injection site 2040 can further includean elastomeric seal 2046, which is shown in a closed configuration inwhich fluid access is not permitted into a fluid passageway 2048. Smallcrevices can exist between the housing 2042 and the elastomeric seal2046 at an end of the needleless injection site 2040 that is insertedinto sterilization chamber 1922. As the connection interface 2044cooperates with the connection interface 1930 defined by the sidewall1912 to draw the tip of the needleless injection site 2040 into thesterilization chamber 1922, the pad 1970 can be compressed so as togenerally conform to the crevices. Compression of the pad 1970 likewisecan expel antiseptic 1933, which, in some instances, can fill inportions of the crevices that the pad 1970 may not be able to contactdirectly. As the pad 1970 is compressed, the seal 2046 can remain closedso as to prevent antiseptic 1933 from entering the fluid passageway2048. With reference again to FIG. 29, if present, the one or moreextensions 1974, due to their positioning over the threads 1031,additionally can rub or scrub the side surfaces of the needlelessinjection site 2040. Thus, a thorough rubbing and sterilization of theneedleless injection site 2040 can be accomplished via the cap 1902, andthe performance of the cap 1902 in this regard can exceed that achievedvia standard swabbing protocols and can be less susceptible to humanerror.

With reference to FIG. 33, the needleless injection site 2060 cancomprise a Q-Syte® port available from Becton, Dickinson and Company.The needleless injection site 2060 can include a housing 2062 and anelastomeric seal 2066, which is shown in a closed configuration in whichfluid access is not permitted into a fluid passageway 2068. As with theneedleless injection site 2040, small crevices can exist between thehousing 2062 and the elastomeric seal 2066. However, the crevices canexist at a side portion of the needleless injection site 2060, ratherthan at its tip. Nevertheless, as the needleless injection site 2060 isadvanced into the cap 1902, the pad 1970 can be compressed so as togenerally conform to these differently shaped crevices. Compression ofthe pad 1970 likewise can expel antiseptic 1933, which, in someinstances, can fill in portions of the crevices that the pad 1970 maynot be able to contact directly. The seal 2066 can be maintained in theclosed position during the coupling procedure, so as to prevent any ofthe antiseptic 1933 from entering the fluid passageway 2068.

With reference to FIG. 34, the needleless injection site 2080 cancomprise a SmartSite® port available from Cardinal Health, Inc. Theneedleless injection site 2080 can include a housing 2082 and anelastomeric seal 2086, which is shown in a closed configuration in whichfluid access is not permitted into a fluid passageway 2088. As with theneedleless injection sites 2040, 2060, small crevices can exist betweenthe housing 2082 and the elastomeric seal 2086. However, these crevicescan be in yet different positions than those of the needleless injectionsites 2040, 2060. Nevertheless, as the needleless injection site 2080 isadvanced into the cap 1902, the pad 1970 can be compressed so as togenerally conform to these differently shaped crevices. Compression ofthe pad 1970 likewise can expel antiseptic 1933, which, in someinstances, can fill in portions of the crevices that the pad 1970 maynot be able to contact directly. The seal 2086 can be maintained in theclosed position during the coupling procedure so as to prevent any ofthe antiseptic 1933 from entering the fluid passageway 2088.Additionally, each of the needleless injection sites 2040, 2060, 2080may advance into the cap 1902 by different amounts. The cap 1902 thuscan be adaptable and versatile. Additional, non-limiting examples ofneedleless injection sites with which the cap 1902 can selectivelycouple include the Clearlink® Site available from Baxter and theInVision-Plus® available from Rymed.

Features, usage, and operation of the assembly 1900 can resemble that ofone or more of the assemblies described above. For example, in theillustrated embodiment, the pad 1970 is in an uncompressed or expandedstate when the sterilization chambers 1922, 1958 in which it is housedare in a pre-use, sealed condition. Additionally, the caps 1902, 1904are coaxial with each other with open ends that face in oppositedirections. Likewise, the caps 1902, 1904 are connected to each otherwhen the assembly 1900 is in a pre-use state.

However, certain differences can exist. For example, in the illustratedembodiment, the caps 1902, 1904 cannot be removed from each other.Moreover, the assembly 1900 includes a single pad 1970 that is used inboth caps 1902, 1904. Although not shown in the drawings, it isunderstood that each cap 1902, 1904 can be coupled with a separatemedical connector such that the pad 1970 is compressed from both endswhen the caps 1902, 1904 are in a coupled state.

FIG. 35 illustrates another embodiment of an assembly 2100, which canresemble one or more of the assemblies described above, particularly theassembly 1900, in certain respects. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “21.” The assembly 2100 can include caps 2102, 2104, suchas the caps 1902, 1904, that are fixedly, permanently, or integrallyconnected with each other. Covers such as the covers 1934, 1938, whichare not shown in FIG. 35, can be used with the caps 2102, 2104. Theassembly 2100 can include a single housing 2110 that defines twosterilization chambers 2122, 2158. The housing 2110 can include apartition 2120 that separates the sterilization chambers 2122, 2158 fromeach other such that the chambers 2122, 2158 are fluidly separated fromone another. Each chamber 2122, 2158 can include a separate pad 2132,2170 therein.

FIGS. 36 and 37 illustrate another embodiment of an assembly 2200, whichcan resemble one or more of the assemblies described above, particularlythe assemblies 1900 and 2100, in certain respects. Accordingly, likefeatures are designated with like reference numerals, with the leadingdigits incremented to “22.” The assembly 2200 can include a female cap2202 and a male cap 2204 that are fixedly, permanently, or integrallyconnected with each other. The assembly can include a housing 2210,which can include a sidewall 2252 that defines a sterilization chamber2258 and a connection interface 2242. Covers 2234, 2238, such as thecovers 1934, 1938, can be used with the caps 2202, 2204.

The female cap 2202 can be substantially the same as the female cap1902. However, the male cap 2204 can differ from the male cap 1904 incertain respects. For example, the cap 2204 can include a sealing member2290. In the illustrated embodiment, the sealing member 2290 is shapedsubstantially as a conical disk. The sealing member 2290 can include aseal region 2292 which, in the illustrated embodiment, is rounded andprojects toward an open end of the sterilization chamber 2258 whensituated therein. Alternatively, the sealing member 2290 may be in theform of other shapes such as, for example, a square shape or othernon-circular shapes. Further, the sealing member 2290 and the sealregion 2292 may be a separate components that are integrally connected.The sealing member 2290 can include one or more ports 2294, which candefine openings or channels 2293 that extend between opposing faces ofthe sealing member 2290. Other configurations of the ports 2294 are alsocontemplated, such as, for example, self-sealing slits. In otherconfigurations wherein the sealing member 2290 is a non-circular shape,the ports can be eliminated since the antiseptic can flow around thesides of the sealing member 2290. In some embodiments, the sealingmember 2290 can be relatively rigid so as to maintain a pre-formedshape, but may be configured to readily form a liquid-tight seal with amale luer of a medical connector. The sealing member 2290 can be formedof any suitable material, such as an elastomer or any thermoplastic suchas polypropylene, polycarbinate, acrylonitrile butadiene styrene (ABS),polyvinyl chloride (PVC), or rigid or semi-rigid thermoset plastic. Thesealing member 2290 can be formed in any suitable fashion, such as viamolding or die cutting.

The sealing member 2290 can be coupled with a biasing element 2276,which can be configured to resist or oppose movement of the sealingmember 2290. Stated otherwise, the biasing element 2276 can provide abias to the sealing member 2290 in a direction of an initial position ofthe sealing member 2290, such as that shown in FIG. 37, once the sealingmember 2290 has been displaced from that initial position. Accordingly,in the embodiment depicted in FIG. 37, the biasing element 2276 biasesthe sealing member 2290 in a proximal direction when the sealing member2290 is displaced distally. The terms “proximal” and “distal,” when usedherein relative to a cap, are such that a medical device is insertedinto a proximal end of the cap and advanced toward a distal end of thecap. Accordingly, in the illustrated embodiment, the proximal ends ofthe caps 2202, 2204 are at opposite ends of the assembly 2200 and thedistal ends of the caps 2202, 2204 are fixedly joined with each other.

The male cap 2204 can include a rim 2253, similar to the lip 1953, whichcan include one or more vents 2259. However, in the illustratedembodiment, the rim 2253 is more recessed from a proximal end of the cap2204 (e.g., deeper within the cavity 2258). A portion of a pad 2270 thatis positioned within the sterilization chamber 2258 can be shorter thana corresponding portion of the pad 1970, so as to more readily fit belowthe more recessed rim 2253. As shown in FIG. 37, the pad 2270 can beseated beneath the sealing member 2290, and the sealing member 2290 canbe seated beneath the rim 2253 when the male cap is in the pre-useconfiguration. In some embodiments, the pad 2270 is in an uncompressedstate (e.g., a longitudinally uncompressed state) when situated as shownin FIG. 37. The pad 2270 can include an antiseptic 2233 therein.

In the illustrated embodiment, the pad 2270 is resiliently compressiblesuch that the biasing element 2276 comprises the pad 2270. Statedotherwise, compression of the pad 2270 gives rise to a biasing forcethat tends to restore the pad 2270 to its uncompressed state. Thebiasing force may increase with greater compression of the pad 2270. Insome embodiments, the pad 2270 is fixedly secured to the sealing member2290, such as by an adhesive or any suitable lamination technique. Inother embodiments, the sealing member 2290 is not secured to the pad2270, but movement of the sealing member 2290 within the sterilizationchamber 2258 can nevertheless be constrained by a proximal end of thepad 2270 and a distal edge of the rim 2253.

The sealing member 2290 can aid in maintaining the antiseptic 2233within the pad 2270 when the cap 2204 is in a pre-use condition. Forexample, in some embodiments, only a small surface area of the proximalend of the pad 2270 that is directly beneath the ports 2294 of thesealing member 2290 is directly exposed to air when the proximal end ofthe cap 2204 is uncovered. Accordingly, evaporative loss of theantiseptic 2233 can be slowed. Moreover, in other or furtherembodiments, the ports 2294 may be defined by channels that aresufficiently small to prevent liquid antiseptic 2233 from passingthrough them when the pressure on both sides of the sealing member 2290is balanced. However, the ports 2294 may permit liquid antiseptic 2233to pass through them when the pressure on one side of the sealing member2290 is greater than the pressure on the other side of the sealingmember 2290, as discussed further below. The pad 2270 itself can also beconfigured to retain the antiseptic 2233 until it is compressed.

In some embodiments, an outer edge of the sealing member 2290 can form aliquid-tight seal with an inner surface of the sidewall 2252 when thecap 2204 is in the pre-use state. In further embodiments, the seal canbe maintained as the sealing member 2290 is moved distally within thesterilization chamber 2258 such that liquid antiseptic 2233 is onlypermitted to bypass the sealing member 2290 through the ports 2294. Inother embodiments, an outer edge of the sealing member 2290 may not forma liquid-tight seal with the sidewall 2252, whether initially or afterhaving been moved from the pre-use condition, such that antiseptic 2233can bypass the sealing member 2290 around its outer edge.

FIG. 38 illustrates an early stage of coupling a medical connector 2000with the cap 2204. A tip 2021 of a male luer 2020 contacts the sealregion 2292 of the sealing member 2290. In the illustrated embodiment, aportion of the sealing member 2290 extends into a lumen 2022 of theconnector 2000 such that the contact is primarily between an inner edgeof the tip 2021 and a thin band of the sealing member 2290. Such anarrangement can assist in forming a liquid-tight seal due to arelatively higher pressure that results between the tip 2021 and thesealing member 2290 when forces (e.g., an insertion force on the tip andan oppositely directed biasing force on the sealing member) aredistributed over relatively smaller areas. Such an arrangement likewisecan allow antiseptic to contact much or all of an external surface ofthe luer 2020, including a distal surface of the tip 2021.

In the illustrated embodiment, contact between the tip 2021 and thesealing member 2290 occurs just prior to engagement of a connection 2012of the connector 2000 with the connection interface 2242. In otherembodiments, the connection interfaces 2012, 2242 can engage each otherprior to contact between the tip 2021 and the sealing member 2290. Ineither case, as the connection interfaces 2012, 2242 cooperate with eachother to connect the cap 2204 to the medical connector 2000 (e.g., asthe cap 2204 is threaded onto the connector 2000), a liquid-tight sealis formed or maintained between the seal region 2292 of the sealingmember 2290 and the tip 2021 of the male luer 2020.

FIG. 39 illustrates a late or final stage of coupling the medicalconnector 2000 with the cap 2204. To arrive at this stage, cap 2204 isadvanced over the male luer 2020 to a greater extent. As a result, theluer 2020 is advanced further into the sterilization chamber 2258,thereby moving the sealing member 2290 distally and compressing the pad2270. Compression of the pad 2270 forces antiseptic 2233 out of the pad2270. Moreover, as the pad 2270 is compressed, the volume of the portionof the sterilization chamber 2258 that is on the distal side of thesealing member 2290 is reduced, thereby increasing the pressure in thatportion of the sterilization chamber 2258. As a result, the antiseptic2233 is forced through the ports 2294 into the portion of thesterilization chamber 2258 on the proximal side of the sealing member2290. Due to the seal between the sealing member 2290 and the luer 2020,the antiseptic 2233 is prevented from entering the lumen 2022 of theluer 2020, and thus is prevented from contacting or mixing with medicalfluid that may be within the lumen 2022 when the cap 2204 is coupledwith the medical connector 2000 and/or that may flow through the lumen2022 after the cap 2204 has been removed from the connector 2000. Theantiseptic 2233 can fill the open region of the sterilization chamber2258 on the proximal side of the sealing member 2290.

As the luer 2020 is advanced distally in the sterilization chamber 2258,another seal, or partial seal, can be formed between an outer surface ofthe luer 2020 and an inner surface of the rim 2253. Where present, theseal can be substantially liquid-tight. However, the vents 2259 caninterrupt the seal so as to permit antiseptic 2233 to exit from thechamber 2258. In further embodiments, a proximal or distal surface ofthe rim 2253 can be covered with a covering, such as, for example,Tyvek® or other nonwoven material, which can filter microbes from theair entering the sterilization chamber 2258 via the vents 2259, yet canpermit antiseptic 2233 to pass through it so as to exit from thesterilization chamber 2258. In other embodiments, the rim 2253 isuninterrupted (e.g., is free of vents 2259) such that an uninterruptedseal can be formed between the rim 2253 and the male luer 2020.

With continued reference to FIG. 39, when the cap 2204 is connected tothe medical device 2000, antiseptic 2233 can fill the sterilizationchamber 2258 between the seals formed by contact between the luer 2020and the sealing member 2290 and between the luer 2020 and the rim 2253.An outer surface of the luer 2020 between these two sealed regions ofthe luer 2020 thus can be bathed in the antiseptic 2233 and sterilizedthereby. As mentioned with respect to the assembly 1900, the rim 2253can be positioned at a deeper or a more shallow position relative to thehousing 2252, which can result in sterilization of a smaller or greatersurface area of the luer 2020, respectively. In certain embodiments inwhich the proximal seal between the rim 2253 and the male luer 2020 isinterrupted (e.g., where the rim 2253 includes vents 2259), antiseptic2233 can be permitted to exit from the chamber 2258. In someembodiments, the vents 2259 are sufficiently large to permit antiseptic2233 to exit from the chamber 2258 freely once the antiseptic 2233 hasbeen expelled from the pad 2270. Antiseptic 2233 that exits from thechamber 2258 through the vents 2259 can sterilize portions of the maleluer 2020 that are proximal of the rim 2253.

When the cap 2204 is removed from the medical device 2000, it cannaturally or automatically return to the orientation shown in FIG. 37.In particular, the resiliently compressible pad 2270 can move thesealing member 2290 distally to its pre-use position. In so doing, theexpanding portion of the sterilization chamber 2258 that is distal ofthe sealing member 2290 can have a decreased pressure such thatantiseptic 2233 is forced back through the ports 2294 of the sealingmember 2290 in a distal direction. The expanding pad 2270 can soak up orabsorb the returned antiseptic 2233.

In other embodiments, the caps 2202, 2204 can more closely resemble thecaps 2102, 2104 described above. For example, the cap 2202 can have aseparate pad, which is separated from the pad 2270 by a partition. Instill other embodiments, the caps 2202, 2204 can be readily disconnectedfrom each other, and in further embodiments, may be configured forselective reconnection with each other in manners such as thosedescribed with respect to other caps herein.

FIGS. 40-45 illustrate another embodiment of a cap 2304, which canresemble one or more of the caps described above in certain respects.For example, the cap 2304 can replace or readily be altered to replaceany of the caps 1004, 1104, 1204, 1304, 1404, 1504, 1604, 1804, 1904,2104, 2204 in the systems 1000, 1100, 1200, 1300, 1400, 1500, 1600,1800, 1900, 2100, 2200 described above. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “23.”

The cap 2304 can include a housing 2350 having a sidewall 2352 and abase wall 2354 that define a sterilization chamber 2358. The housing2350 can further include a coupling interface 2342. The cap 2304 caninclude a biasing member 2376, which can comprise a resilientlycompressible pad 2370, which can in turn include an antiseptic 2333therein. The cap 2304 can further include a sealing member 2390, whichincludes a sealing region 2392 and one or more ports 2394, which includechannels 2393 that extend through the sealing member 2390.

The sidewall 2352 of the housing 2350 can be different from that of theillustrated embodiment of the cap 2204. In particular, at least aportion of an inner surface of the sidewall 2352 (e.g., a proximalregion thereof) can be tapered so as to form a liquid-tight seal with amale luer. For example, at least a portion of the inner surface of thesidewall 2352 can comply with ISO standards (e.g., ISO 594-1:1986 andISO 594-2:1998) for forming a seal with a male luer. In the illustratedembodiment, the sidewall 2352 is devoid of any inwardly projecting rimsthat could interrupt complementarities between the sidewall 2352 and amale luer.

FIGS. 41-45 illustrate consecutive stages of the cap 2304 being coupledwith a medical device 2000. As shown in FIG. 41, a tip 2021 of a maleluer 2020 can be received within the sterilization chamber 2358 prior tocontacting the sealing member 2390. Stated otherwise, the sealing member2390 can be recessed relative to a proximal end of the sidewall 2352 bya distance that is sufficiently great to permit at least a portion ofthe male luer 2020 to be received within the sidewall 2352 before themale luer contacts the sealing member 2390.

In FIG. 42, the luer 2020 has been advanced further within thesterilization chamber 2358 so as to contact the seal region 2392 of thesealing member 2390. In the illustrated embodiment, the connectioninterface 2342 of the cap 2304 engages a connection interface 2012 ofthe medical connector 2000 just prior to contact being made between thetip 2021 of the luer 2020 and the seal region 2392. The connectioninterfaces 2342, 2012 thus can assist in the creation of a fluid-tightseal between the luer 2020 and the sealing member 2390.

The sealing member 2390 can remain in the initial or pre-use positionthat is shown in both FIGS. 41 and 42 until the seal has been formedbetween the luer 2020 and the sealing member 2390. Further advancementof the luer 2020 into the sterilization chamber 2358 can strengthen theseal due to the spring force that arises as the pad 2370 is compressed.When the sealing member 2390 is in the initial orientation, the ports2394 can prevent antiseptic 2333 from passing through them. Also, thecomposition of the pad 2370 or the affinity of the pad 2370 to absorbantiseptic 2333 will determine the retention of the antiseptic 2333 inthe pad 2370.

In FIG. 43, the luer 2020 has been advanced slightly further into thesterilization chamber 2358, thereby compressing the pad 2370 somewhatand forcing antiseptic 2333 through the ports 2394. As schematicallyshown by wavy lines, the antiseptic 2333 begins to fill the spacebetween the sealing member 2390 and the tip 2021 of the luer 2020. Theantiseptic 2333 does not, however, enter into a lumen of the luer 2020due to the seal between the luer 2020 and the sealing member 2390.

In FIG. 44, the luer 2020 has been advanced even further into thesterilization chamber 2358, thereby compressing the pad 2370 to agreater extent and forcing additional antiseptic 2333 through the ports2394. Although the outer surface of the luer 2020 appears to be nearlyparallel to and in contact with an inner surface of the tapered portionof the sidewall 2352, a seal has not yet been formed in this area.Accordingly, the antiseptic 2333 can fill not only the space between thesealing member 2390 and the tip 2021 of the luer 2020, but also thesmall amount of space between the luer 2020 and the sidewall 2352. Theluer 2020 thus can be covered in antiseptic 2333 and sterilized thereby.In some embodiments, the antiseptic 2333 remains within portions of thespace between the luer 2020 and the sidewall 2352 only temporarily, asadditional advancement of the luer 2020 can close this space to form aseal.

FIG. 45 illustrates a final or fully coupled stage, or an end-of-strokeorientation, in which the luer 2020 has been advanced even further intothe sterilization chamber 2358 such that the luer 2020 forms a seal withthe sidewall 2352. Antiseptic 2333 can be retained in all open portionsof the sterilization chamber 2358 that are between the seal formed bythe luer 2020 and the sealing member 2390 and the seal formed by theluer 2020 and the sidewall 2352. In the illustrated embodiment, only asmall portion of the luer 2020, which includes the tip 2021, is incontinual contact with the portion of the antiseptic 2333 thus retained.This portion of the luer 2020 can be bathed by the antiseptic 2333 andsterilized thereby. In other embodiments, larger portions of the luer2020 can be bathed.

The seal formed by the luer 2020 and the sealing member 2390 and theseal formed by the luer 2020 and the sidewall 2352 is accomplished byappropriate sizing of the individual components. The sizing is subjectto and based upon the ISO luer taper specification, which implies arange of axial engagement of 2 millimeters. All manufactured componentscan vary with tolerance limits between a maximum and minimum materialcondition. The maximum material condition and minimum material conditionindicate large and small components, respectively. When all combinationsof maximum and minimum material condition parts are considered, thevariation in mating depth in the axial direction is 2 millimeters. Theminimum material condition in this case is also the case of maximummating depth (or stroke). In other words, the minimum material conditionis the loosest fit, and the maximum material condition is the tightestfit of the taper. A minimum dispense stroke of 1 millimeter indicatesthat the components have been dimensioned such that for the tightestfitting luer 2020 (i.e., maximum material condition), a minimum of 1millimeter dispense stroke will exist. Hence, a minimum of 1 millimeterof seal movement will exist prior to luer engagement.

FIG. 46 illustrates another embodiment of a cap 2304′ in anend-of-stroke orientation. The cap 2304′ is substantially the same asthe cap 2304 just discussed. For example, a substantial portion of aninterior surface of the sidewall 2352 is tapered so as to becomplementary to the male luer 2020. However, the sidewall 2352 includesone or more venting channels or vents 2353 therein that prevent thesidewall 2352 from sealing with the male luer 2020. The illustrated vent2352 extends from a proximal end of the sidewall 2352 in a longitudinaldirection to a position just beyond (or distal of) an end-of-strokeposition of the tip 2021 of the male luer 2020. Accordingly, afterliquid-impervious contact is established between the male luer 2020 andthose portions of the sidewall 2352 having a taper complementary to themale luer 2020, antiseptic 2333 can still exit the chamber 2358 via thevent 2353. In certain embodiments, the coupled connection interfaces2012, 2342 can permit the antiseptic 2333 to pass through them so as toprovide additional venting of the chamber 2358. For example, threadedconnection interfaces 2012, 2342 can permit antiseptic 2333 that hasexited from the chamber 2358 to spiral about an outer surface of thesidewall 2352 and/or otherwise seep in a distal direction.

In various embodiments, the cap 2304′ comprises one or more, two ormore, three or more, or four or more vents 2353. One or more of thevents 2353 can be substantially linear in a longitudinal direction (asshown) and/or can define alternate orientations. For example in someembodiments, one or more vents 2353 can be angled relative to alongitudinal axis of the cap 2304′ (e.g., can be helical), or caninclude a portion that is so angled. One or more of the vents 2353 canextend any suitable distance between the proximal end of the sidewall2352 and the base wall 2354. For example, in various embodiments, thevents 2353 extend no less than about ¼, no less than about ⅓, no lessthan about ½, no less than about ⅔, or no less than about ¾ the distancebetween the proximal end of the sidewall 2352 and the base wall 2354.Where suitable, one or more vents 2353 can be incorporated intoembodiments of the caps described above, as well as those describedhereafter.

FIG. 47 illustrates another embodiment of a cap 2404, which can resembleone or more of the caps described above, particularly the caps 2304,2304′, in certain respects. Accordingly, like features are designatedwith like reference numerals, with the leading digits incremented to“24.” The cap can include a housing 2450, a biasing member 2476, and asealing member 2490. The housing 2450 can have a sidewall 2452 and abase wall 2454 that define a sterilization chamber 2458. The housing2450 can further define one or more ports 2494. In the illustratedembodiment, the port 2494 comprises a longitudinal groove 2459 extendinga distance along the sidewall 2452. The longitudinal distance which thegroove 2459 extends can be varied as desired. In some embodiments, thelongitudinal distance is greater than or equal to a stroke lengththrough which the sealing member 2490 is displaced when the cap 2404 isconnected to a medical connector for reasons discussed hereafter,although such is not required.

The sealing member 2490 can be devoid of channels, and may act in aplunger-like fashion. The sealing member 2490 can form aliquid-impermeable seal with the sidewall 2452 when in the pre-useconfiguration shown in FIG. 47. However, distal displacement of thesealing member 2490 can move a proximal end of the sealing member 2490past a proximal end of the channel 2494, thereby opening the channel2494. This can permit an antiseptic 2433 to be forced from a pad 2470 bythe displaced sealing member 2494 and moved through the channel 2494,thereby entering the portion of the sterilization chamber 2458 which isproximal to the sealing member 2490. In embodiments where thelongitudinal length of a channel 2459 is greater than or equal to astroke length through which the sealing member 2490 is displaced,antiseptic 2433 can be permitted to pass through the channel 2494 duringall stages of the displacement.

In the illustrated embodiment, the biasing member 2476 includes aresiliently compressible pad 2477, although additional or othercomponents are possible (e.g., a compressible spring). The pad 2477 isseparated from the pad 2470 by a barrier 2478, which can comprise anysuitable material capable of preventing passage of the antiseptic 2433.For example, in some embodiments, the barrier 2478 comprises a plasticfilm or disk. The barrier 2478 thus can restrain the antiseptic 2433 toa predetermined portion of the sterilization chamber 2458 that isclosest to the sealing member 2490. Such an arrangement can permit theusage of less antiseptic 2433, as a greater portion of the antiseptic2433 can be expelled from the pad 2470.

In some embodiments, both of the pads 2470, 2477 comprise the samematerial, while in other embodiments different materials may be selectedfor desired properties. For example, the pad 2470 may comprise a moreabsorbent foam while the pad 2477 may comprise a springier foam. In someembodiments, both pads 2470, 2477 can provide a bias to the sealingmember 2490 when they are compressed such that the biasing member 2476can be said to include both pads 2470, 2477. In still other or furtherembodiments, the biasing member 2476 can comprise a spring or other atleast somewhat resiliently deformable element in place of the pad 2477.

Although in the illustrated embodiment, the sealing member 2490 isdevoid of ports, other embodiments can include ports in addition to orinstead of the channels 2494 in the sidewall 2452. Likewise, it isunderstood that channels 2494 could be included in other embodiments ofcaps described herein in addition to or in place of ports throughsealing members. Similar substitutions and rearrangements are possiblewith respect to other features of the cap 2404, such as the two-partbiasing member 2476 and the barrier 2478.

FIGS. 48 and 49 illustrate another embodiment of a cap 2504, which canresemble one or more of the caps described above, particularly the caps2304, 2304′, 2404, in certain respects. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “25.” The cap can include a housing 2550, a biasingmember 2576, and a sealing member 2590. The housing 2550 can have asidewall 2552 that defines a sterilization chamber 2558. The housing2550 can further define a bathing recess 2555 within the sterilizationchamber 2558, which can be included in a tapered region at a proximalend of the sidewall 2552. As shown in FIG. 49, antiseptic 2533 can beretained within the bathing recess 2555 and maintained in contact withan outer surface of a male luer 2020. Accordingly, a greater portion ofthe luer 2020 than just a tip 2021 thereof can be maintained in contactwith the antiseptic 2533 when the luer 2020 is in an end-of-strokeposition.

The housing 2550 can further define a vent 2598 having a cover 2599. Thevent 2598 can be defined by a channel that extends from an interior ofthe sidewall 2552 to an exterior thereof. A distal end of the vent 2598can open into the bathing recess 2555, and a proximal end of the vent2598 can be at a proximal end of the sidewall 2552. The vent 2598 canfunction in manners such as those described above with respect to othervents.

In some embodiments, the cover 2599 can comprise a material, such as,for example, Tyvek® or other nonwoven material, which can filtermicrobes from the air entering the sterilization chamber 2558 via thevent 2598 and can permit antiseptic 2533 to exit from the sterilizationchamber 2558.

With continued reference to FIGS. 48 and 49, the antiseptic 2533 can beheld within the sterilization chamber 2533 without pads. A biasingmember 2576 can include a compression spring 2579. A sealing member 2590can form a fluid-tight seal with the sidewall 2552 to retain theantiseptic 2533 within a reservoir portion of the chamber 2533. Whilethe sealing member 2590 can resemble any of the sealing membersdiscussed above, the illustrated embodiment includes ports 2594 thathave two-way valves 2597 therein. In various embodiments, the two-wayvalves 2597 are formed of self-sealing slits and/or the two-way valves2597 can be disposed within channels through the sealing member 2590.

FIG. 50 illustrates another embodiment of an assembly 2600, which canresemble one or more of the assemblies described above, particularly theassembly 1800, in certain respects. Accordingly, like features aredesignated with like reference numerals, with the leading digitsincremented to “26.” The assembly 2600 can include a cap 2602 and cap2604 that are coupled with each other when in a pre-use state and thatcan be removed from each other. In particular, the caps 2602, 2604 canbe coupled with each other via a sealing mechanism. In the illustratedembodiment, the caps 2602, 2604 are coupled with each other via asealing sleeve 2691.

With reference to FIG. 51, the cap 2602 can include a housing 2610,which can include a sidewall 2612 and a base wall 2613. The housing 2610can include a substantially cylindrical region toward a proximal endthereof, which can be flattened and taper toward the narrower base wall2613. Such a shape can provide a convenient handle at a distal end ofthe cap 2602. A cavity 2623 can be formed at an interior of the sidewall2612 and the base wall 2613, which can reduce material costs for the cap2602.

The sidewall 2612 can define a sterilization chamber 2622, which caninclude a connection interface 2630 that includes threads 2631. Theconnection interface 2630 can be configured to attach the cap 2602 to amedical connector in a secure yet selectively removable manner. Thesterilization chamber 2622 can further include a pad 2632.

A proximal surface 2624 of the sidewall 2612 can define a seal inhibitor2625 that is configured to prevent the cap 2602 from forming afluid-tight seal with a medical connector, such as a needlelessinjection site, when it is coupled therewith. For example, in theillustrated embodiment, the proximal surface 2624 of the sidewall 2612is substantially castellated such that it defines a series of offsetcontact regions 2626 and venting regions 2627. In the illustratedembodiment, each of the contact regions 2626 and venting regions 2627includes a planar surface that is substantially perpendicular to alongitudinal axis of the cap 2602. The contact regions 2626 are at amore proximal position than are the venting regions 2627. Accordingly,when the cap 2602 is coupled with certain embodiments of needlelessinjection sites, the contact regions 2626 can come into contact withsurfaces of the needleless injection sites that project outwardly,whereas the venting regions 2627 can avoid making any such contact.

For example, in arrangements such as those depicted in FIGS. 32 and 33,the cap 2602 can be advanced onto a needleless injection site 2040, 2060sufficiently to bring the planar surfaces of the contact regions 2626into contact with a radially outwardly projecting planar surfaces of theneedleless injection site 2040, 2060. However, in such a configuration,the venting regions 2627 would be spaced from the outwardly projectingplanar surface of the needleless injection site 2040, 2060 so as not toform a seal therewith. The cap 2602 thus would be permitted to vent viathe venting regions 2627. As further discussed below, otherconfigurations of the seal inhibitor 2625 are also possible. Moreover,in some embodiments, the cap 2625 is devoid of a seal inhibitor 2625.

With reference to FIGS. 51 and 53, an exterior surface of the sidewall2612 can define another connection interface 2640 that is configured tocouple the cap 2602 with a connection interface 2695 of the sleeve 2691.In the illustrated embodiment, the connection interfaces 2640, 2695couple with each other via a friction-fit engagement. The friction fitcan be sufficiently strong to provide a fluid-tight seal between the cap2602 and the sleeve 2691, yet can allow the cap 2602 to be removed fromthe sleeve 2691 via mere manipulation by a medical practitioner (e.g.,without the use of ancillary tools). The fluid-tight seal can preventevaporative loss of antiseptic from the pad 2632 and/or can maintain thesterility of the sterilization chamber 2622. In other or furtherembodiments, the connection interfaces 2640, 2695 can include threads orother suitable attachment features.

The cap 2602 can include a flange 2615 having an outer diameter largerthan an inner diameter of the end of the sleeve 2691 that connects withthe cap 2602. The flange 2615 can prevent the cap 2602 from beinginserted into the sleeve 2690 too deeply. In other or furtherembodiments, the flange 2615 can cooperate with an end surface of thesleeve 2690 to create a liquid-tight seal (see FIG. 54). For example, insome embodiments, a sealing member, such as an “O” ring, is includedbetween the flange 2615 and the end of the sleeve 2690 to provide theliquid-tight seal.

With reference to FIG. 52, the cap 2604 can include a housing 2650 thatincludes a sidewall 2652 and a base wall 2654, which can cooperate todefine a cavity 2659 similar to the cavity 2623 described above.Likewise, the housing 2650 can define a substantially cylindrical shapeat a proximal end of the cap 2604, which flattens and tapers toward thebase wall 2654.

The sidewall 2652 can define a sterilization chamber 2658, which caninclude a sealing member 2690 and a biasing member 2676. The sealingmember 2690 and the biasing member 2676 can resemble any suitablecombination of these components, and features thereof, described above.In the illustrated embodiment, the biasing member 2676 comprises a pad2670.

A portion of the sidewall 2652 can define a connection interface 2642,which includes one or more threads 2643 in the illustrated embodiment.The connection interface 2642 can be configured to attach the cap 2604to a medical connector in a secure yet selectively removable manner.

With reference to FIGS. 52 and 53, the sidewall 2652 can define anadditional connection interface 2680, which can cooperate with aconnection interface 2692 defined by the sleeve 2691 to couple the cap2604 with the cap 2602. The connection interface 2680 of the cap 2604can include a groove 2683, which may be substantially annular and extendabout a periphery of the cap 2604. The connection interface 2692 of thesleeve 2691 can include a complementary inward projection 2693, whichlikewise can be substantially annular. The interfaces 2680, 2692, whencoupled with each other, can provide a fluid-tight seal between the cap2604 and the sleeve 2690. In other embodiments, the connectioninterfaces 2680, 2690 can instead define a friction-fit seal, such asthat provided by the illustrated embodiment of the connection interfaces2640, 2695 described above. In still other or further embodiments, aflange 2661 defined by the housing 2650 can cooperate with an endsurface of the sleeve 2691 to create a liquid-tight seal (see FIG. 54),which can prevent evaporative loss of antiseptic from the pad 2670and/or maintain the sterility of the sterilization chamber 2658. Forexample, in some embodiments, a sealing member, such as an “O” ring, isincluded between the flange 2659 and the end of the sleeve 2691 toprovide the liquid-tight seal.

With reference to FIG. 54, when the assembly 2600 is in a fully coupledor pre-use state, a proximal end of the sidewall 2652 of the cap 2604 isreceived within the cavity 2622 defined by the sidewall 2612 of the cap2602. In some embodiments, the sidewall 2652 of the cap 2604 does notcontact any portion of the sidewall 2612 of the cap 2602 in this pre-useconfiguration, nor does the sidewall 2652 contact the pad 2632 that iswithin the cap 2602. Such a configuration can result in a relativelycompact assembly 2600 in which each cap 2602, 2604 can be quicklyprepared for use. In other embodiments, the sidewalls 2652, 2612 maycontact or couple with each other (e.g., via the connection interfaces2642, 2630) and/or the sidewall 2652 may contact the pad 2632 in thepre-use configuration. In still other embodiments, the sidewalls 2652,2612 may be spaced from each other such that the sidewall 2652 is notreceived within the cavity 2622.

FIG. 55 illustrates another embodiment of an assembly 2700, which canresemble one or more of the assemblies described above, particularly theassemblies 1800, 2600, in certain respects. Accordingly, like featuresare designated with like reference numerals, with the leading digitsincremented to “27.” The assembly 2700 can include a cap 2702 and cap2704 that are coupled with each other when in a pre-use state via asealing sleeve 2791.

The assembly 2700 can include one or more separation assists 2707, 2708,which can aid in removal of the cap 2702 and/or the cap 2704 from thesleeve 2791. In the illustrated embodiment, the separation assists 2707,2708 each includes a complementary recess/protrusion pair. Inparticular, a flange 2715 of the cap 2702 defines a recess 2716 that issized and dimensioned to receive therein a protrusion 2799 that isdefined by an edge 2798 of the sleeve 2791. The recess 2716 and theprotrusion 2799 cooperate with each other as a separation assist 2707.Similarly, a flange 2761 of the cap 2704 defines a recess 2762 that issized and dimensioned to receive therein a protrusion 2797 that isdefined by an edge 2796 of the sleeve 2791. The recess 2762 and theprotrusion 2797 cooperate with each other as a separation assist 2708.

Focusing now on the separation assist 2707, the recess 2716 can includetwo substantially planar surfaces that meet at a rounded base. Theplanar surfaces can be at an angle relative to a plane that isperpendicular to a longitudinal axis (or central axis) of the cap 2702(e.g., a plane defined by portion of the flange 2715 that does notinclude the recess 2716, in the illustrated embodiment). For example, inthe illustrated embodiment, each of the planar surfaces of the recess2716 defines an angle of about 20 degrees relative to the perpendicularplane. Similarly, the protrusion 2799 can include two substantiallyplanar surfaces that meet at a rounded apex. The planar surfaces can beat the same angle relative to the perpendicular plane as are the planarsurfaces of the recess 2716. For example, in the illustrated embodiment,each of the planar surfaces of the protrusion 2799 defines an angle ofabout 20 degrees relative to a plane defined by the portion of the edge2798 of the sleeve 2791 that does not include the protrusion 2799.

When the cap 2702 is joined with the sleeve 2791 in a pre-useconfiguration (similar to that shown in FIG. 54), the planar portions ofthe recess 2716 and of the protrusion 2799 can be in close proximity toeach other or can contact each other. In order to separate the cap 2702from the sleeve 2791, the cap 2702 can be rotated relative the sleeve2791, which can cause opposing planar surfaces of the recess 2716 andthe protrusion 2799 to contact each other and slide past each other.This interaction can convert the rotational movement of the cap 2702about a common axis of the cap 2702 and the sleeve 2791 intotranslational movement of the cap 2702 away from the sleeve 2791 alongthe common axis. Due to the symmetry of the planar surfaces of each ofthe recess 2716 and the protrusion 2799 of the illustrated embodiment,the cap 2702 can be rotated in either direction to achieve the samelifting action via the separation assist 2707 that tends to move the cap2702 away from the sleeve 2791.

In other embodiments, the separation assist 2707 can be configured toaid in separating the cap 2702 from the sleeve 2791 only when the cap2702 is rotated in one predetermined direction (e.g., either clockwiseor counterclockwise). For example, one planar surface may be at about 20degrees relative to the perpendicular plane, whereas the other planarsurface may be at a about 90 degrees relative to the perpendicular plane(i.e., approximately parallel to or extending through a central axis ofthe cap 2702). In other embodiments, one or more of the planar surfacesof the recess 2716 and/or the protrusion 2799 may be at larger orsmaller angles relative to the perpendicular plane. For example, invarious embodiments, a set of complementary planes may be at an angle ofno more than about 15 degrees, no more than about 20 degrees, no morethan about 30 degrees, no more than about 45 degrees, no more than about60 degrees, or no more than about 75 degrees. Other configurations ofthe separation assist 2707 are also possible. For example, in someembodiments, the complementary surfaces of the recess 2716 and theprotrusion 2799 can define angles as just described, but the surfacesmay be rounded or otherwise non-planar.

The foregoing discussion regarding the separation assist 2707 appliesequally to the separation assist 2708. In the illustrated embodiment,the separation assist 2707 and the separation assist 2708 aresubstantially identical, such that the recess 2762 and the protrusion2797 likewise include complementary planar surfaces that are at an angleof about 20 degrees relative to a plane oriented perpendicularly througha central axis of the cap 2704 and the sleeve 2791. In otherembodiments, the arrangements of the separation assists 2707, 2708 maybe different from each other. For example, the planar surfaces of theseparation assist 2707 may be at a larger or smaller angle than those ofthe separation assist 2708 so as to provide a different amount ofseparation force. Moreover, in some embodiments, the assembly 2700includes a number of separation assists 2707 equal to the number ofseparation assists 2708, whereas in other embodiments, the assembly 2700may include more or fewer separation assists 2707 as compared with thenumber of separation assists 2708. For example, in the illustratedembodiment, the assembly 2700 includes one separation assist 2707 andtwo separation assists 2708.

In the illustrated embodiment, the two separation assists 2708 are atdiametrically opposite positions. Such an orientation can aid inmaintaining the cap 2704 and the sleeve 2791 in a substantially coaxialorientation as the cap 2704 is being removed, which can prevent anelongated sidewall 2752 from contacting an inner surface of the sleeve2791 and thereby potentially complicating removal of the cap 2704. Inother arrangements, additional separation assists 2708 may be used, andthe separation assists 2708 may be equally spaced from each other abouta perimeter of the sleeve 2791.

Other arrangements of the separation assists 2707, 2708 arecontemplated. For example, in some embodiments, the caps 2702, 2704include one or more of the protrusions 2799, 2797, respectively, whereasthe sleeve 2791 includes one or more of the recesses 2716, 2762.

FIGS. 56 and 57 illustrate another embodiment of a cap 2802, which insome embodiments can be used in place of the cap 2602 in the assembly2600. In other embodiments, the cap 2802 can be modified so as to beused in place of the cap 2702 in the assembly 2700, such as by alteringa flange 2815 of the cap 2802 to include a recess.

The cap 2802 can include a seal inhibitor 2825 having a differentarrangement from that shown with respect to the caps 2602, 2702. In theillustrated embodiment, the seal inhibitor 2825 is defined by a proximalsurface 2824 of a sidewall 2812 of the cap 2802, which defines arounded, sinusoidal contour. In particular, the proximal surface 2824can define two contact regions 2826 and two venting regions 2827. In theillustrated embodiment, the contact regions 2826 are at diametricallyopposite positions and the venting regions 2827 likewise are atdiametrically opposite positions. The contact regions 2626 are at a moreproximal position than are the venting regions 2627. As discussed abovewith respect to the cap 2602, the venting regions 2827 can prevent thecap 2802 from forming a seal with a medical connector, and can permitventing of the cap 2802 when it is coupled with the medical connector.

As shown in FIG. 58, the proximal surface 2824 of the cap 2802 can bewell-suited for coupling with a removable cover 2834 such as theremovable covers discussed above. Accordingly, various embodiments ofthe cap 2802 either can be readily fitted with a cover 2834 anddistributed for individual use, or can be incorporated into an assembly,such as the assemblies 2600, 2700 described above, and distributed foruse in a dual-cap system. Such versatility can reduce manufacturingcosts, such as by eliminating tooling costs.

The caps described herein can be formed of, or coated with variouscolored materials or coatings. In some embodiments, the caps eachinclude the same color. In other embodiments, the caps include differentcolors. Coloring the caps can, in some instances, provide advantages,such as ready identification of the type of cap, ready matching of aparticularly colored cap with a particular type of medical connector,and the like.

The foregoing disclosure recites various embodiments that includesystems configured for use with a pair of separated medical connectors.Examples of first means for coupling a male cap with a first medicalconnector include the connection interfaces 1042, 1142, 1342, 1542,1842, 1942, 2242, 2342, 2642 of the caps 1004, 1104, 1304, 1504, 1804,1904, 2204, 2304, 2304′, 2604. Examples of first means for sterilizing amale luer of a first medical connector include the pads 1070, 1170,1370, 1570, 1870, 2170, 2270, 2370, 2470, 2670. Examples of second meansfor coupling the female cap with a second medical connector include theconnection interfaces 1030, 1130, 1530, 1830, 1930, 2230, 2630 of thecaps 1002, 1102, 1502, 1802, 1902, 2202, 2602. Examples of second meansfor sterilizing at least a portion of a second medical connector includethe pads 1032, 1132, 1332, 1532, 1832, 2132, 2632. Examples of means forcoupling the male and female caps in a pre-use configuration include theconnection interfaces 1040 and 1042; 1140 and 1180; 1240 and 1280; 1340and 1380; 1440 and 1480; 1540 and 1580; 1840, 1891, 1842, and 1892; and2640, 2695, 2680, and 2692. Examples of means for sealing a lumen of amale luer include the sealing members 2290, 2390, 2490, 2590, and 2690.Examples of means for biasing a means for sealing a lumen of a male luerinclude the biasing members 2276, 2376, 2476, 2576, and 2676.

It will be understood by those having skill in the art that many changesmay be made to the details of the above-described embodiments withoutdeparting from the underlying principles presented herein. For example,any suitable combination of features of the various embodiments ofassemblies described above is contemplated.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

It should be appreciated that in the above description of embodiments,various features are sometimes grouped together in a single embodiment,figure, or description thereof for the purpose of streamlining thedisclosure. This method of disclosure, however, is not to be interpretedas reflecting an intention that any claim require more features thanthose expressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing this Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment. This disclosure includes all permutations of theindependent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements recited inmeans-plus-function format are intended to be construed in accordancewith 35 U.S.C. §112 ¶6. It will be apparent to those having skill in theart that changes may be made to the details of the above-describedembodiments without departing from the underlying principles of theinvention.

1. A method of disinfecting a male luer connector of the type including a post having a lumen through which fluid flows, the method comprising: providing a male-disinfecting cap including a receiving portion having a sidewall defining a chamber into which the post of the male luer connector can be received; a biasing member disposed in the chamber; a sealing member disposed in the chamber; and an antiseptic agent disposed in the chamber; and moving the cap in relation to the male luer connector so that (i) the post is received into the chamber, (ii) the biasing member urges the sealing member toward the post to cover the lumen and maintain the sealing member against the lumen, and, (iii) while the sealing member covers the lumen so as to inhibit at least the antiseptic agent from entering the lumen, at least a portion of the antiseptic agent is caused to come into contact with the post.
 2. A method according to claim 1, wherein the sealing member is configured to permit the flow of the antiseptic agent past the sealing member to the post.
 3. A method according to claim 2, wherein the sealing member includes at least one channel near its periphery.
 4. A method according to claim 1, further comprising providing a pad disposed in the chamber abutting the sealing member, the pad containing the antiseptic.
 5. A method according to claim 1, further comprising providing a cover disposed over an opening of the chamber.
 6. A method according to claim 5, wherein the cover comprises an impervious pliable material.
 7. A method according to claim 6, wherein the impervious pliable material is a foil.
 8. A method according to claim 1, wherein a portion of the sidewall of the receiving portion has a taper that narrows toward an interior of the chamber.
 9. A method according to claim 8, wherein the taper is near an opening of the chamber.
 10. A method according to claim 8, further comprising engaging the post against the taper of the sidewall. 